Education

STABILITY & DEGRADATION EVIDENCE

Peptide Stability & Degradation Evidence

Why do some peptides remain stable for weeks or months while others require much more careful handling? Explore the governed evidence, peptide by peptide.

Peptide stability is not one fixed property of a molecule's name -- it depends on the exact molecule, its formulation (free base vs. a specific salt form), its physical state (lyophilized powder vs. reconstituted solution), the surrounding environment (temperature, light, oxygen, trace metals), and how it is handled (agitation, freeze/thaw cycles, container contact).

This page distinguishes what has actually been measured from what is inferred, and keeps every peptide-specific number traceable to a governed evidence record. Where the current approved evidence packet does not cover a subject, that gap is stated explicitly rather than filled in with an estimate.

Three Kinds of Stability

Chemical stability

Whether the peptide's covalent molecular structure stays intact -- no bond cleavage, no unwanted new bonds, no altered amino-acid residues. A chemically changed peptide is a different molecule, even if it still looks the same.

Physical stability

Whether the peptide's physical form stays consistent -- no aggregation, precipitation, or loss of the intended solid/solution state. A peptide can be chemically intact but physically unstable (e.g. aggregated), or vice versa.

Microbiological / in-use stability

Whether a preparation stays free of microbial contamination once a container has been opened or a lyophilized product has been reconstituted. This is a use-and-handling question, separate from whether the peptide molecule itself has chemically or physically changed.

These three concepts are independent. A peptide can pass one and fail another -- treating them as a single combined 'stability' score hides which specific problem, if any, actually applies.

Why Peptides Degrade

Chemical and physical change can come from many directions at once -- the molecule itself, its formulation, and its environment all contribute.

Oxidation

Some peptide residues are susceptible to oxidation. Whether oxidation is a meaningful stability risk depends on the molecule and the formulation.

Deamidation

A sequence-dependent chemical change that can alter a peptide over time. Its rate can change substantially with pH, temperature, and local sequence.

Hydrolysis

Can cleave susceptible chemical bonds. Stress studies commonly evaluate hydrolytic susceptibility across different pH conditions.

Aggregation

Not purely a storage-temperature issue. Can be influenced by the molecule, concentration, formulation, interfaces, impurities, and mechanical stress.

Interface / Adsorption

Some peptide and protein formulations are sensitive to interfaces and surfaces, which is one reason container and excipient choices can matter.

Disulfide-Related Change

Where applicable: for molecules that contain disulfide bonds, disulfide scrambling or exchange can be another route of structural change.

Read the full Stability & Formulation guide→

Lyophilized vs. Reconstituted

A lyophilized (freeze-dried) peptide and a reconstituted solution of the same peptide are not the same stability problem. Introducing water or another diluent increases molecular mobility and opens solution-phase degradation pathways that a dry solid does not experience in the same way -- which is why formulation and storage choices tend to matter more, not less, after reconstitution.

Step 1
Freeze
The material is frozen as the first conceptual stage of the process.
Step 2
Primary Drying
Most of the water is removed under reduced pressure.
Step 3
Secondary Drying
Residual moisture is further reduced from the dried matrix.
Step 4
Dried Product
A solid material whose stability still depends on formulation, residual moisture, and storage conditions.

Key limitation

Dry does not mean indefinitely stable.

Accelerated Stability Testing

Accelerated stability testing intentionally stresses a formulation at an elevated temperature (and often humidity) for a shorter period, as a faster way to observe degradation behavior than waiting out a full real-time storage study. Pharmaceutical science has long used temperature-dependence models (commonly associated with the Arrhenius equation) to reason about this relationship in principle.

Stress / Accelerated

Learn how a product can change.

Real-Time

Measure change under defined storage conditions.

Do not extrapolate

Elevated-temperature data is not the same measurement as refrigerator-condition data. Converting a 40°C accelerated result into an implied 2-8°C degradation rate requires a validated extrapolation model for that exact formulation -- this page never performs that conversion, and displays only the condition each data point was actually tested at.

BPC-157: HPLC purity across six salt/free-base forms

The approved evidence packet includes a direct accelerated-stability comparison across six BPC-157 forms, measured by HPLC purity/assay at Day 0, Day 76, and Day 120.

Direct measured data

HPLC purity by form, Day 0 / 76 / 120

40°C accelerated -- not a refrigerator study

Measured values by form and day, tabular form of the chart above
Form	Day 0	Day 76	Day 120
Free BPC-157	99.3%	98.1%	97.4%
BPC-157 monoacetate	99.2%	97.8%	95.3%
Sodium salt	99.4%	99.5%	99.4%
Disodium salt	99.4%	99.7%	99.4%
TRIS salt	99.5%	99.5%	99.4%
diTRIS salt	99.5%	99.5%	99.5%

Do not extrapolate

These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.

Semaglutide: patent in-use assay by preserved formulation

The approved evidence packet includes a patent application with a genuine Day 0/28/56/84 assay (potency) time series for two specific high-concentration, preserved semaglutide compositions, each held at two in-use temperatures.

Direct measured data

Semaglutide assay (%) by composition, Day 0 / 28 / 56 / 84

Preserved patent formulations -- not Ozempic, not BAC water

Toggle forms shown on the chart

Composition 1 (phenol-preserved, ~30 mg/mL) — 5°C (in-use)Composition 1 (phenol-preserved, ~30 mg/mL) — 30°C (in-use)Composition 3 (m-cresol-preserved, ~30 mg/mL) — 5°C (in-use)Composition 3 (m-cresol-preserved, ~30 mg/mL) — 30°C (in-use)

Measured values by form and day, tabular form of the chart above
Form	Day 0	Day 28	Day 56	Day 84
Composition 1 (phenol-preserved, ~30 mg/mL) — 5°C (in-use)	99.9%	101%	98.2%	97.6%
Composition 1 (phenol-preserved, ~30 mg/mL) — 30°C (in-use)	99.9%	102.4%	94.1%	91.5%
Composition 3 (m-cresol-preserved, ~30 mg/mL) — 5°C (in-use)	102.6%	100.3%	97.2%	98.2%
Composition 3 (m-cresol-preserved, ~30 mg/mL) — 30°C (in-use)	102.6%	101.7%	92.6%	91.5%

Do not extrapolate

These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.

Wave 1 Evidence Coverage Matrix

What kind of evidence was located for each Wave 1 subject, across eleven evidence dimensions. This describes evidence coverage, not peptide quality -- there is no score, grade, ranking, or traffic-light rating anywhere in this table.

Peptide	Direct analytical data	Lyophilized data	Solution data	2-8°C evidence	Room-temperature evidence	Freeze data	BAC-water-specific evidence	Approved-product evidence	Regulatory evidence	Peer-reviewed evidence	Routine-storage degradation curve
Retatrutide	NO MATCH LOCATED	NO MATCH LOCATED	LIMITED	NO MATCH LOCATED	NO MATCH LOCATED	NO MATCH LOCATED	NO MATCH LOCATED	NOT APPLICABLE	NO MATCH LOCATED	LIMITED	NO MATCH LOCATED
Semaglutide	YES	LIMITED	YES	YES	YES	LIMITED	NO MATCH LOCATED	YES	YES	YES	YES -- specific formulations only
Tirzepatide	YES	NO MATCH LOCATED	YES	YES	YES	LIMITED	NO MATCH LOCATED	YES	YES	YES	YES -- specific formulations only
GHK-Cu	YES	NO MATCH LOCATED	YES	NO MATCH LOCATED	LIMITED	NO MATCH LOCATED	NO MATCH LOCATED	NOT APPLICABLE	NO MATCH LOCATED	YES	NO MATCH LOCATED
CJC-1295 without DAC	NO MATCH LOCATED	LIMITED	LIMITED	LIMITED	NO MATCH LOCATED	LIMITED	NO MATCH LOCATED	NOT APPLICABLE	YES	NO MATCH LOCATED for stability	NO MATCH LOCATED
CJC-1295 with DAC	NO MATCH LOCATED	LIMITED	LIMITED	LIMITED	NO MATCH LOCATED	LIMITED	NO MATCH LOCATED	NOT APPLICABLE	YES	NO MATCH LOCATED for stability	NO MATCH LOCATED
Somatropin	YES	YES	YES	YES	YES	LIMITED	LIMITED	YES	YES	YES	YES -- specific formulations only
HCG	YES	LIMITED	YES	YES	YES	LIMITED	YES -- approved formulations	YES	YES	LIMITED	YES -- recombinant liquid formulation only
Thymosin Alpha-1	YES	YES	YES	LIMITED -- storage requirement cited, no direct 2-8 curve frozen	YES -- 25°C accelerated	NO MATCH LOCATED	NO MATCH LOCATED	LIMITED -- ZADAXIN registration confirmed, authoritative stability label not retrieved	LIMITED	LIMITED -- prior paper cited by patent, primary full text not retrieved	NO MATCH LOCATED
PT-141	YES	NO MATCH LOCATED	YES	YES -- finished VYLEESI registration stability at 5°C	YES -- finished product at 25°C/60% RH	LIMITED -- label says do not freeze; no freeze-thaw analytical series	NO MATCH LOCATED	YES	YES	YES	YES -- exact finished formulation
Melanotan II	LIMITED -- identity/purity only, not stability	NO MATCH LOCATED	NO MATCH LOCATED	NO MATCH LOCATED	NO MATCH LOCATED	NO MATCH LOCATED	NO MATCH LOCATED	NOT APPLICABLE	NO MATCH LOCATED	YES -- analytical characterization, not storage stability	NO MATCH LOCATED
AOD-9604	YES	YES -- dry/lyophilized-derived solid formulations	NO MATCH LOCATED	YES -- direct 4°C tablet study	YES -- 25°C direct dry-form studies	NO MATCH LOCATED	NO MATCH LOCATED	NOT APPLICABLE	NO MATCH LOCATED	NO MATCH LOCATED for stability	YES -- exact dry tablet formulation at 4°C
IGF-1 LR3	LIMITED -- manufacturer technical testing, no public longitudinal primary dataset	YES -- manufacturer technical	YES -- manufacturer technical	YES -- manufacturer technical only	LIMITED -- ambient shipping statement, not a routine analytical curve	NO MATCH LOCATED	NO MATCH LOCATED	NOT APPLICABLE	NO MATCH LOCATED	NO MATCH LOCATED for exact LR3 stability	NO MATCH LOCATED under strict direct-evidence rule
Selank	YES	YES	YES	NO MATCH LOCATED direct	LIMITED -- 35/40°C accelerated, not routine room-temperature storage	NO MATCH LOCATED	NO MATCH LOCATED	NO MATCH LOCATED authoritative	NO MATCH LOCATED	NO MATCH LOCATED for exact storage study	NO MATCH LOCATED

Retatrutide

Direct analytical data: NO MATCH LOCATED
Lyophilized data: NO MATCH LOCATED
Solution data: LIMITED
2-8°C evidence: NO MATCH LOCATED
Room-temperature evidence: NO MATCH LOCATED
Freeze data: NO MATCH LOCATED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NOT APPLICABLE
Regulatory evidence: NO MATCH LOCATED
Peer-reviewed evidence: LIMITED
Routine-storage degradation curve: NO MATCH LOCATED

Semaglutide

Direct analytical data: YES
Lyophilized data: LIMITED
Solution data: YES
2-8°C evidence: YES
Room-temperature evidence: YES
Freeze data: LIMITED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: YES
Regulatory evidence: YES
Peer-reviewed evidence: YES
Routine-storage degradation curve: YES -- specific formulations only

Tirzepatide

Direct analytical data: YES
Lyophilized data: NO MATCH LOCATED
Solution data: YES
2-8°C evidence: YES
Room-temperature evidence: YES
Freeze data: LIMITED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: YES
Regulatory evidence: YES
Peer-reviewed evidence: YES
Routine-storage degradation curve: YES -- specific formulations only

GHK-Cu

Direct analytical data: YES
Lyophilized data: NO MATCH LOCATED
Solution data: YES
2-8°C evidence: NO MATCH LOCATED
Room-temperature evidence: LIMITED
Freeze data: NO MATCH LOCATED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NOT APPLICABLE
Regulatory evidence: NO MATCH LOCATED
Peer-reviewed evidence: YES
Routine-storage degradation curve: NO MATCH LOCATED

CJC-1295 without DAC

Direct analytical data: NO MATCH LOCATED
Lyophilized data: LIMITED
Solution data: LIMITED
2-8°C evidence: LIMITED
Room-temperature evidence: NO MATCH LOCATED
Freeze data: LIMITED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NOT APPLICABLE
Regulatory evidence: YES
Peer-reviewed evidence: NO MATCH LOCATED for stability
Routine-storage degradation curve: NO MATCH LOCATED

CJC-1295 with DAC

Direct analytical data: NO MATCH LOCATED
Lyophilized data: LIMITED
Solution data: LIMITED
2-8°C evidence: LIMITED
Room-temperature evidence: NO MATCH LOCATED
Freeze data: LIMITED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NOT APPLICABLE
Regulatory evidence: YES
Peer-reviewed evidence: NO MATCH LOCATED for stability
Routine-storage degradation curve: NO MATCH LOCATED

Somatropin

Direct analytical data: YES
Lyophilized data: YES
Solution data: YES
2-8°C evidence: YES
Room-temperature evidence: YES
Freeze data: LIMITED
BAC-water-specific evidence: LIMITED
Approved-product evidence: YES
Regulatory evidence: YES
Peer-reviewed evidence: YES
Routine-storage degradation curve: YES -- specific formulations only

HCG

Direct analytical data: YES
Lyophilized data: LIMITED
Solution data: YES
2-8°C evidence: YES
Room-temperature evidence: YES
Freeze data: LIMITED
BAC-water-specific evidence: YES -- approved formulations
Approved-product evidence: YES
Regulatory evidence: YES
Peer-reviewed evidence: LIMITED
Routine-storage degradation curve: YES -- recombinant liquid formulation only

Thymosin Alpha-1

Direct analytical data: YES
Lyophilized data: YES
Solution data: YES
2-8°C evidence: LIMITED -- storage requirement cited, no direct 2-8 curve frozen
Room-temperature evidence: YES -- 25°C accelerated
Freeze data: NO MATCH LOCATED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: LIMITED -- ZADAXIN registration confirmed, authoritative stability label not retrieved
Regulatory evidence: LIMITED
Peer-reviewed evidence: LIMITED -- prior paper cited by patent, primary full text not retrieved
Routine-storage degradation curve: NO MATCH LOCATED

PT-141

Direct analytical data: YES
Lyophilized data: NO MATCH LOCATED
Solution data: YES
2-8°C evidence: YES -- finished VYLEESI registration stability at 5°C
Room-temperature evidence: YES -- finished product at 25°C/60% RH
Freeze data: LIMITED -- label says do not freeze; no freeze-thaw analytical series
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: YES
Regulatory evidence: YES
Peer-reviewed evidence: YES
Routine-storage degradation curve: YES -- exact finished formulation

Melanotan II

Direct analytical data: LIMITED -- identity/purity only, not stability
Lyophilized data: NO MATCH LOCATED
Solution data: NO MATCH LOCATED
2-8°C evidence: NO MATCH LOCATED
Room-temperature evidence: NO MATCH LOCATED
Freeze data: NO MATCH LOCATED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NOT APPLICABLE
Regulatory evidence: NO MATCH LOCATED
Peer-reviewed evidence: YES -- analytical characterization, not storage stability
Routine-storage degradation curve: NO MATCH LOCATED

AOD-9604

Direct analytical data: YES
Lyophilized data: YES -- dry/lyophilized-derived solid formulations
Solution data: NO MATCH LOCATED
2-8°C evidence: YES -- direct 4°C tablet study
Room-temperature evidence: YES -- 25°C direct dry-form studies
Freeze data: NO MATCH LOCATED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NOT APPLICABLE
Regulatory evidence: NO MATCH LOCATED
Peer-reviewed evidence: NO MATCH LOCATED for stability
Routine-storage degradation curve: YES -- exact dry tablet formulation at 4°C

IGF-1 LR3

Direct analytical data: LIMITED -- manufacturer technical testing, no public longitudinal primary dataset
Lyophilized data: YES -- manufacturer technical
Solution data: YES -- manufacturer technical
2-8°C evidence: YES -- manufacturer technical only
Room-temperature evidence: LIMITED -- ambient shipping statement, not a routine analytical curve
Freeze data: NO MATCH LOCATED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NOT APPLICABLE
Regulatory evidence: NO MATCH LOCATED
Peer-reviewed evidence: NO MATCH LOCATED for exact LR3 stability
Routine-storage degradation curve: NO MATCH LOCATED under strict direct-evidence rule

Selank

Direct analytical data: YES
Lyophilized data: YES
Solution data: YES
2-8°C evidence: NO MATCH LOCATED direct
Room-temperature evidence: LIMITED -- 35/40°C accelerated, not routine room-temperature storage
Freeze data: NO MATCH LOCATED
BAC-water-specific evidence: NO MATCH LOCATED
Approved-product evidence: NO MATCH LOCATED authoritative
Regulatory evidence: NO MATCH LOCATED
Peer-reviewed evidence: NO MATCH LOCATED for exact storage study
Routine-storage degradation curve: NO MATCH LOCATED

"YES -- specific formulations only" does not establish that a generic research vial mixed with bacteriostatic water has the same curve.

What Wave 1 Teaches About Stability

The same active molecule is not one stability story

Tirzepatide, semaglutide, somatropin, and hCG evidence all show that concentration, buffer, preservative, pH, and excipients can materially change stability -- the same active molecule can perform very differently in different formulations.

Chemical and physical stability can diverge

A somatropin study maintained chemical purity and potency for 28 days while one syringe material developed unacceptable turbidity in the same experiment. Chemical purity, physical/aggregation stability, and microbiological in-use safety are kept as separate questions on this page.

Stress testing is not routine-storage behavior

Semaglutide, tirzepatide, and GHK-Cu forced-degradation/accelerated studies reveal real degradation pathways and vulnerabilities, but there is no scientifically valid universal conversion from an elevated-temperature stress result to a refrigerated shelf life without a validated kinetic model for that exact formulation.

Different approved products, different validated handling periods

NOVAREL (30 days) and PREGNYL (60 days) are both hCG products reconstituted with a benzyl-alcohol-preserved diluent, refrigerated -- yet their approved in-use periods differ. The same active molecule plus a different formulation/product can mean a different validated handling period; they are never averaged into one hCG rule.

A metal-peptide complex is its own stability question

GHK-Cu is a copper-peptide complex. A stability-indicating study found strong dependence on pH, oxidative stress, and carrier composition -- uncomplexed GHK evidence is not treated as equivalent to GHK-Cu evidence.

Quick Reference

What kind of evidence, if any, is currently on file for each of these peptides. No single combined score -- each category is shown independently.

Wave 1 adds eight current-catalog subjects with materially different evidence profiles -- from Semaglutide and Somatropin's rich direct analytical data to Retatrutide's confirmed absence of any storage/degradation curve. Each subject still shows its four categories independently.

BPC-157

Direct measured dataOn file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

TB-500

Direct measured dataNot on file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

KPV

Direct measured dataNot on file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

MOTS-c

Direct measured dataNot on file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

Semax

Direct measured dataNot on file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

Ipamorelin

Direct measured dataNot on file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

SS-31(Elamipretide)

Direct measured dataNot on file

Regulatory storage guidanceNot on file

Approved formulation / label dataOn file

Direct routine-condition stability evidenceNot located

View evidence records →

Tesamorelin

Direct measured dataNot on file

Regulatory storage guidanceNot on file

Approved formulation / label dataOn file

Direct routine-condition stability evidenceNot located

View evidence records →

Retatrutide(LY3437943)

Direct measured dataNot on file

Regulatory storage guidanceNot on file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

No approved stability evidence of any kind located

View evidence records →

Semaglutide

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataOn file

Direct routine-condition stability evidenceOn file

Numeric time series available for charting: Yes

View evidence records →

Tirzepatide

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataOn file

Direct routine-condition stability evidenceOn file

Numeric time series available for charting: No

View evidence records →

GHK-Cu(Copper tripeptide-1, Glycyl-L-histidyl-L-lysine copper)

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

CJC-1295 without DAC(CJC-1295 free base)

Direct measured dataNot on file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

CJC-1295 with DAC(CJC-1295 DAC free base)

Direct measured dataNot on file

Regulatory storage guidanceOn file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

Somatropin(Recombinant human growth hormone, rhGH, HGH)

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataOn file

Direct routine-condition stability evidenceOn file

Numeric time series available for charting: No

View evidence records →

HCG(Human chorionic gonadotropin, recombinant hCG, rec-hCG)

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataOn file

Direct routine-condition stability evidenceOn file

Numeric time series available for charting: No

View evidence records →

Thymosin Alpha-1(Thymalfasin)

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

PT-141(Bremelanotide, Bremelanotide acetate)

Direct measured dataOn file

Regulatory storage guidanceOn file

Approved formulation / label dataOn file

Direct routine-condition stability evidenceOn file

Numeric time series available for charting: No

View evidence records →

Melanotan II(MT-II, MT2)

Direct measured dataNot on file

Regulatory storage guidanceNot on file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

No approved stability evidence of any kind located

View evidence records →

AOD-9604(Tyr-hGH 177-191)

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceOn file

Numeric time series available for charting: No

View evidence records →

IGF-1 LR3(LONG R3 IGF-I, Long R3 IGF-I)

Direct measured dataNot on file

Regulatory storage guidanceNot on file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

No approved stability evidence of any kind located

View evidence records →

Selank

Direct measured dataOn file

Regulatory storage guidanceNot on file

Approved formulation / label dataNot on file

Direct routine-condition stability evidenceNot located

View evidence records →

Stability Evidence Library

Every governed stability-evidence record currently approved for display, across every peptide covered so far.

Peptide

Evidence type

Directly measured only

Showing 49 of 49 records

Peptide	Formulation	Evidence type	Condition / Guidance	Evidence detail
BPC-157	Free BPC-157	Direct stability test	40°C (accelerated aqueous stability condition)	Evidence detail Source class Patent analytical experiment Source European Patent EP 0 983 300 B1, Example 12 Publication / identity European Patent Office (EPO) Analytical method HPLC purity/assay (%) Directly measured Yes Exact-formulation match Yes Limitations These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.
BPC-157	BPC-157 monoacetate	Direct stability test	40°C (accelerated aqueous stability condition)	Evidence detail Source class Patent analytical experiment Source European Patent EP 0 983 300 B1, Example 12 Publication / identity European Patent Office (EPO) Analytical method HPLC purity/assay (%) Directly measured Yes Exact-formulation match Yes Limitations These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.
BPC-157	Sodium salt	Direct stability test	40°C (accelerated aqueous stability condition)	Evidence detail Source class Patent analytical experiment Source European Patent EP 0 983 300 B1, Example 12 Publication / identity European Patent Office (EPO) Analytical method HPLC purity/assay (%) Directly measured Yes Exact-formulation match Yes Limitations These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.
BPC-157	Disodium salt	Direct stability test	40°C (accelerated aqueous stability condition)	Evidence detail Source class Patent analytical experiment Source European Patent EP 0 983 300 B1, Example 12 Publication / identity European Patent Office (EPO) Analytical method HPLC purity/assay (%) Directly measured Yes Exact-formulation match Yes Limitations These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.
BPC-157	TRIS salt	Direct stability test	40°C (accelerated aqueous stability condition)	Evidence detail Source class Patent analytical experiment Source European Patent EP 0 983 300 B1, Example 12 Publication / identity European Patent Office (EPO) Analytical method HPLC purity/assay (%) Directly measured Yes Exact-formulation match Yes Limitations These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.
BPC-157	diTRIS salt	Direct stability test	40°C (accelerated aqueous stability condition)	Evidence detail Source class Patent analytical experiment Source European Patent EP 0 983 300 B1, Example 12 Publication / identity European Patent Office (EPO) Analytical method HPLC purity/assay (%) Directly measured Yes Exact-formulation match Yes Limitations These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.
BPC-157	Free base (reconstituted)	Regulatory-reviewed storage evidence	Reconstituted BPC-157 free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C.	Evidence detail Storage / handling guidance Reconstituted BPC-157 free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C. Source class Regulatory briefing Source FDA-reviewed regulatory briefing material (BPC-157 reconstituted storage guidance) Publication / identity FDA regulatory briefing Directly measured No Exact-formulation match Yes Limitations This is regulatory-reviewed storage guidance, not a measured percentage-vs-time degradation curve. No validated 120-day (or any) 2-8°C percentage-degradation curve was located for BPC-157 -- do not present this storage window as measured potency data.
TB-500	Free base (in solvent)	Regulatory-reviewed storage evidence	TB-500 free base, in solvent, reportedly should be stored under sealed, moisture- and light-protected, nitrogen conditions for approximately 6 months at -80°C, or 1 month at -20°C.	Evidence detail Storage / handling guidance TB-500 free base, in solvent, reportedly should be stored under sealed, moisture- and light-protected, nitrogen conditions for approximately 6 months at -80°C, or 1 month at -20°C. Source class Regulatory briefing Source FDA-reviewed regulatory briefing material (TB-500 storage guidance) Publication / identity FDA regulatory briefing Directly measured No Exact-formulation match Yes Limitations No validated 2-8°C refrigerated percentage-vs-time degradation curve was identified for TB-500. These storage windows are regulatory-reviewed handling guidance, not measured potency data, and must not be presented as a percentage degradation curve.
KPV	Aqueous KPV	Regulatory-reviewed storage evidence	Aqueous KPV was reported with storage guidance of approximately 6 months at -80°C, approximately 1 month at approximately -2°C, and approximately 1 week at 10°C.	Evidence detail Storage / handling guidance Aqueous KPV was reported with storage guidance of approximately 6 months at -80°C, approximately 1 month at approximately -2°C, and approximately 1 week at 10°C. Source class Regulatory briefing Source FDA-reviewed regulatory briefing material (KPV storage guidance) Publication / identity FDA regulatory briefing Directly measured No Exact-formulation match Yes Limitations This is storage guidance summarized in an FDA briefing, not a published percentage-vs-time degradation curve. No 120-day 2-8°C percentage curve was established for KPV.
MOTS-c	Reconstituted	Regulatory-reviewed storage evidence	After reconstitution, MOTS-c reportedly stable at +4°C for approximately 2-7 days, or below -18°C for future use.	Evidence detail Storage / handling guidance After reconstitution, MOTS-c reportedly stable at +4°C for approximately 2-7 days, or below -18°C for future use. Source class Regulatory briefing Source FDA-reviewed regulatory briefing material (MOTS-c storage guidance) Publication / identity FDA regulatory briefing Directly measured No Exact-formulation match Yes Limitations No 120-day refrigerated potency curve was located for MOTS-c. This is storage guidance, not measured percentage-degradation data.
Semax	Reconstituted	Regulatory-reviewed storage evidence	After reconstitution, Semax reportedly stable at +4°C for up to approximately 2-7 days.	Evidence detail Storage / handling guidance After reconstitution, Semax reportedly stable at +4°C for up to approximately 2-7 days. Source class Regulatory briefing Source FDA-reviewed regulatory briefing material (Semax storage guidance) Publication / identity FDA regulatory briefing Directly measured No Exact-formulation match Yes Limitations Long-term lyophilized storage guidance must not be interpreted as equivalent stability after reconstitution. No 120-day refrigerated potency curve was located for Semax.
Ipamorelin	Free base (reconstituted)	Regulatory-reviewed storage evidence	Reconstituted ipamorelin free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C.	Evidence detail Storage / handling guidance Reconstituted ipamorelin free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C. Source class Regulatory briefing Source FDA-reviewed regulatory briefing material (ipamorelin storage guidance) Publication / identity FDA regulatory briefing Directly measured No Exact-formulation match Yes Limitations These reported storage windows are not a measured 120-day refrigerated percentage-degradation curve. The approved evidence also notes that stability can be affected by factors including pH, concentration, heat, excipients, impurities, and process conditions.
SS-31Elamipretide	FORZINITY (elamipretide) approved aqueous formulation	Approved-product formulation evidence	FORZINITY (elamipretide), an aqueous 80 mg/mL formulation, is stored at 2-8°C before use. After first opening, the vial may remain refrigerated or at room temperature; an opened vial is discarded after 8 days.	Evidence detail Storage / handling guidance FORZINITY (elamipretide), an aqueous 80 mg/mL formulation, is stored at 2-8°C before use. After first opening, the vial may remain refrigerated or at room temperature; an opened vial is discarded after 8 days. Source class Approved drug label Source FORZINITY (elamipretide) FDA-approved product labeling Publication / identity FDA-approved drug labeling / DailyMed Directly measured No Exact-formulation match Yes Limitations This approved formulation (FORZINITY, 80 mg/mL aqueous) is NOT equivalent to lyophilized SS-31 reconstituted with ordinary bacteriostatic water. Do not transfer this 8-day post-opening handling period to unrelated SS-31/elamipretide formulations or research-material vials.
Tesamorelin	EGRIFTA WR approved formulation, reconstituted with Bacteriostatic Water for Injection	Approved-product formulation evidence	EGRIFTA WR, reconstituted with 1.3 mL Bacteriostatic Water for Injection, is stored at 20-25°C after mixing and discarded 7 days after mixing; the mixed formulation should not be refrigerated.	Evidence detail Storage / handling guidance EGRIFTA WR, reconstituted with 1.3 mL Bacteriostatic Water for Injection, is stored at 20-25°C after mixing and discarded 7 days after mixing; the mixed formulation should not be refrigerated. Source class Approved drug label Source EGRIFTA WR (tesamorelin) FDA-approved product labeling Publication / identity FDA-approved drug labeling / DailyMed Directly measured No Exact-formulation match Yes Limitations This is formulation-specific approved-product handling evidence for EGRIFTA WR. Do not infer that every tesamorelin research vial, or every bacteriostatic-water tesamorelin formulation, behaves identically to this exact approved product.
RetatrutideLY3437943	Clinical study dosage formulation	No matching direct degradation curve located	—	Context (not stability evidence) Clinical Phase 1 dosage formulations were reconstituted with sterile water or 0.9% saline -- this confirms clinical preparation media only. No time/temperature stability curve, no BAC-water data, and no validated shelf-life result exists for retatrutide in the approved evidence packet. Eli Lilly continued to describe retatrutide as investigational (not approved by any regulatory agency) as of July 2026. No pharmaceutical storage stability study with an HPLC/purity/potency-vs-time curve was located for retatrutide. This record must never be presented as a refrigerated shelf life, a 30/60/90/120-day degradation percentage, or a BAC-water storage claim, and semaglutide/tirzepatide stability data must never be transferred to retatrutide.
Semaglutide	Water and buffers over varied pH/buffer strength (preformulation study)	Direct stability test	5, 25, 40, 55, 60, 80°C across study components	Evidence detail What the evidence showed Relative stability at pH 1.2 for one day at 25/40°C; increased degradation observed at pH 4.5-5.5 (near semaglutide's reported isoelectric region); stable for 3 h at 80°C in the reported condition. The publicly accessible abstract does not expose a complete 5°C percentage-vs-time table. Source class Peer-reviewed analytical study Source Influence of Buffering Capacity, pH, and Temperature on the Stability of Semaglutide: A Preformulation Study Publication / identity Journal of Peptide Science (Malgave A, Akbar S, Tiwari A, Hande S, Joseph A, Malayandi R, 2025) Year 2025 Identifiers DOI: 10.1002/psc.70039PMID: 40635175 Analytical method Two orthogonal stability-indicating RP-HPLC methods Directly measured Yes Exact-formulation match No Exact quote “A higher extent of degradation was observed between the pH of 4.5-5.5.” Limitations Does not establish BAC-water or generic refrigerated shelf life. Strong general semaglutide solution-stability record, but concentration/container were not exposed in the accessible abstract.
Semaglutide	Composition 1 (phenol-preserved, ~30 mg/mL)	Direct stability test	5°C (in-use)	Evidence detail What the evidence showed Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here. Source class Patent analytical experiment Source Article of Manufacture for Semaglutide Compositions Publication / identity U.S. patent application / Justia reproduction Year 2026 publication Identifiers Patent: US patent application 20260174835 (related WO2026083250A1) Analytical method Assay (potency) plus separately-tracked aggregate and related-substance measurements Directly measured Yes Exact-formulation match Yes Exact quote “maintaining specification compliance for up to three months (84 days).” Limitations These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.
Semaglutide	Composition 1 (phenol-preserved, ~30 mg/mL)	Direct stability test	30°C (in-use)	Evidence detail What the evidence showed Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here. Source class Patent analytical experiment Source Article of Manufacture for Semaglutide Compositions Publication / identity U.S. patent application / Justia reproduction Year 2026 publication Identifiers Patent: US patent application 20260174835 (related WO2026083250A1) Analytical method Assay (potency) plus separately-tracked aggregate and related-substance measurements Directly measured Yes Exact-formulation match Yes Exact quote “maintaining specification compliance for up to three months (84 days).” Limitations These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.
Semaglutide	Composition 3 (m-cresol-preserved, ~30 mg/mL)	Direct stability test	5°C (in-use)	Evidence detail What the evidence showed Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here. Source class Patent analytical experiment Source Article of Manufacture for Semaglutide Compositions Publication / identity U.S. patent application / Justia reproduction Year 2026 publication Identifiers Patent: US patent application 20260174835 (related WO2026083250A1) Analytical method Assay (potency) plus separately-tracked aggregate and related-substance measurements Directly measured Yes Exact-formulation match Yes Exact quote “maintaining specification compliance for up to three months (84 days).” Limitations These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.
Semaglutide	Composition 3 (m-cresol-preserved, ~30 mg/mL)	Direct stability test	30°C (in-use)	Evidence detail What the evidence showed Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here. Source class Patent analytical experiment Source Article of Manufacture for Semaglutide Compositions Publication / identity U.S. patent application / Justia reproduction Year 2026 publication Identifiers Patent: US patent application 20260174835 (related WO2026083250A1) Analytical method Assay (potency) plus separately-tracked aggregate and related-substance measurements Directly measured Yes Exact-formulation match Yes Exact quote “maintaining specification compliance for up to three months (84 days).” Limitations These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.
Semaglutide	Analytical test solutions	Direct stability test	25°C; 60°C wet heat	Evidence detail What the evidence showed Forced-degradation endpoints (single measurement per stress protocol, not a time series): 12.00% degradation in 0.1 M HCl/25°C/10 min; 13.00% in 0.1 M NaOH/25°C/5 min; 14.80% with 10% H2O2/25°C/20 min; 12.35% after direct light/25°C/24 h; 12.60% after wet heat/60°C/60 min. Source class Peer-reviewed analytical study Source A multimodal HPLC stability indicating approach for the estimation of Semaglutide and Tirzepatide in bulk, pharmaceutical dosage forms, and rat plasma: a six-edged sustainability appraisal Publication / identity BMC Chemistry (2026) Year 2026 Identifiers DOI: 10.1186/s13065-025-01716-7PMID: 41588418 Analytical method HPLC-DAD stability-indicating approach (forced degradation) Directly measured Yes Exact-formulation match No Exact quote “the obtained degradation was 11.84% and 12.35% for TIR and SEM, respectively” Limitations These are deliberate forced-degradation stress endpoints, not routine storage. Not BAC water. A useful mechanism/stressor record, never shelf-life guidance.
SemaglutideOZEMPIC	Current OZEMPIC multi-dose formulation: disodium phosphate dihydrate 1.42 mg/mL, propylene glycol 14 mg/mL, phenol 5.5 mg/mL, water	Approved-product formulation evidence	OZEMPIC is stored at 2-8°C before use. After first use, the pen can be stored for 56 days at either 2-8°C or 15-30°C; protect from excessive heat/sunlight and do not freeze.	Evidence detail Storage / handling guidance OZEMPIC is stored at 2-8°C before use. After first use, the pen can be stored for 56 days at either 2-8°C or 15-30°C; protect from excessive heat/sunlight and do not freeze. Source class Approved drug label Source OZEMPIC (semaglutide) injection, solution Publication / identity DailyMed / FDA (Novo Nordisk labeling) Year Current labeling accessed 2026 Identifiers Regulatory ID: DailyMed setid adec4fd2-6858-4c99-91d4-531f5f2a2d79 Directly measured No Exact-formulation match Yes Exact quote “the pen can be stored for 56 days” Limitations Strong formulation-specific handling evidence. Does not transfer to research semaglutide or BAC-water vials.
Tirzepatide	Tirzepatide with NaCl tonicity agent and dibasic sodium phosphate (specific examples at 50 and 60 mg/mL)	Direct stability test	5°C, 25°C, 30°C	Evidence detail What the evidence showed 50 mg/mL + NaCl: >89% tirzepatide purity after 6 months at 30°C. 50/60 mg/mL formulations: acceptable purity supported for at least 6 months at 5°C and 25°C. SEC aggregation below 1% after at least 6 months at 5°C, and at or below 1% at 30°C, for tested strengths. Single reported endpoint (~6 months); no separate Day-0 baseline value was supplied, so this is not represented as a plotted chart. Source class Patent analytical experiment Source Tirzepatide compositions and use Publication / identity WIPO / Google Patents reproduction (Inventors Michael J. Koenig, Ken Kangyi Qian) Year 2024 Identifiers Patent: WO2024006662A1; PCT/US2023/068925 Analytical method Stability-indicating RP-HPLC for purity; SEC-HPLC/UV for high-molecular-weight species/aggregation Directly measured Yes Exact-formulation match Yes Exact quote “tirzepatide aggregation below 1 % for all strengths studied at 5°C.” Limitations Do not transfer to generic BAC-water/research vial. Broad two-year patent embodiment claims should not be treated as equivalent to the experimentally shown six-month results.
Tirzepatide	Analytical test solutions	Direct stability test	25°C; 60°C wet heat	Evidence detail What the evidence showed Forced-degradation endpoints (single measurement per stress protocol, not a time series): 16.90% degradation in 0.1 M HCl/25°C/10 min; 18.97% in 0.1 M NaOH/25°C/20 min; 15.91% with 10% H2O2/25°C/60 min; 11.84% after direct light/25°C/24 h; 17.90% after wet heat/60°C/90 min. Source class Peer-reviewed analytical study Source A multimodal HPLC stability indicating approach for the estimation of Semaglutide and Tirzepatide in bulk, pharmaceutical dosage forms, and rat plasma: a six-edged sustainability appraisal Publication / identity BMC Chemistry (2026) Year 2026 Identifiers DOI: 10.1186/s13065-025-01716-7PMID: 41588418 Analytical method HPLC-DAD stability-indicating approach (forced degradation) Directly measured Yes Exact-formulation match No Limitations Forced degradation only, not BAC water or routine storage.
TirzepatideZEPBOUND	Current ZEPBOUND single-dose formulation	Approved-product formulation evidence	ZEPBOUND is stored at 2-8°C; if needed, may be kept at or below 30°C for a total of up to 21 days for specified presentations. Protect from light; do not freeze.	Evidence detail Storage / handling guidance ZEPBOUND is stored at 2-8°C; if needed, may be kept at or below 30°C for a total of up to 21 days for specified presentations. Protect from light; do not freeze. Source class Approved drug label Source ZEPBOUND (tirzepatide) injection Publication / identity DailyMed / FDA (Eli Lilly labeling) Year Current labeling accessed 2026 Identifiers Regulatory ID: DailyMed setid 487cd7e7-434c-4925-99fa-aa80b1cc776b Directly measured No Exact-formulation match Yes Exact quote “up to a total of 21 days.” Limitations Not generic tirzepatide stability; no BAC-water equivalence.
GHK-CuCopper tripeptide-1, Glycyl-L-histidyl-L-lysine copper	Water and pH 4.5-7.4 buffers; forced acid/base/oxidative conditions; carrier compatibility experiments (copper-complexed GHK-Cu, not uncomplexed GHK)	Direct stability test	60°C for aqueous/buffer and acid/base tests; ~22°C for oxidative test	Evidence detail What the evidence showed No degradation seen in water or pH 4.5-7.4 buffers over 2 weeks at 60°C. Forced-stress endpoints: 0.5 M HCl, 60°C, 1 week: 19.7% degraded (80.3% remaining). 0.5 M NaOH, 60°C, 24 h: 14.1% degraded (85.9% remaining). 0.5% H2O2, ~22°C, 1 h: 15.8% degraded. Degradation was hydrolytic cleavage under basic and oxidative stress, less so under acidic stress, with first-order profiles; carrier composition mattered (Span 60 niosomes compatible; negatively charged dicetyl phosphate reduced stability). Source class Peer-reviewed analytical study Source Physicochemical characterization of native glycyl-L-histidyl-L-lysine tripeptide for wound healing and anti-aging: a preformulation study for dermal delivery Publication / identity Pharmaceutical Development and Technology (Badenhorst T, Svirskis D, Wu Z) Year 2016 (Epub 2014) Identifiers DOI: 10.3109/10837450.2014.979944PMID: 25384620 Analytical method Validated stability-indicating RP-HPLC; HPLC-MS Directly measured Yes Exact-formulation match Yes Exact quote “stable in water and in pH (4.5-7.4) buffers for at least two weeks at 60°C.” Limitations Not a 2-8°C shelf-life curve. Topical formulation-development context; no BAC-water data. Do not substitute uncomplexed-GHK evidence for GHK-Cu -- this record measures the copper complex explicitly.
CJC-1295 without DACCJC-1295 free base	Free base (bulk drug substance, crystalline solid)	Regulatory-reviewed storage evidence	-20°C	Evidence detail Storage / handling guidance CJC-1295 free base, a crystalline solid, is stored at -20°C and is reported to remain stable for 4 or more years. Source class Regulatory briefing Source December 4, 2024 Pharmacy Compounding Advisory Committee meeting -- CJC-1295 review Publication / identity U.S. FDA Year 2024 Identifiers Regulatory ID: FDA PCAC briefing PDF Directly measured No Exact-formulation match Yes Exact quote “stored at -20°C, and the BDS remains stable for 4 or more years.” Limitations FDA cites an underlying commercial source, not a peer-reviewed direct analytical curve. Do not transfer to CJC-1295 acetate, Modified GRF(1-29), Sermorelin, native GHRH fragments, or any DAC-containing form -- identity must remain separate.
CJC-1295 without DACCJC-1295 acetate	Acetate salt of CJC-1295 no-DAC free base	Regulatory-reviewed storage evidence	2-8°C sealed powder; -20°C powder; -80°C in solvent	Evidence detail Storage / handling guidance CJC-1295 acetate as a lyophilized powder is reported for sealed 2-8°C storage; reported up to 3 years at -20°C (powder); in solvent, reported stable up to 1 year when stored at -80°C. Source class Regulatory briefing Source December 4, 2024 PCAC meeting -- CJC-1295 review Publication / identity U.S. FDA (nominator CoA summary) Year 2024 Identifiers Regulatory ID: FDA PCAC briefing PDF Directly measured No Exact-formulation match Yes Exact quote “in solvent is reported to remain stable up to 1 year when stored at -80°C.” Limitations CoA/vendor provenance, not a public analytical curve. FDA notes missing characterization (impurity/aggregate/endotoxin testing); stability is sensitive to manufacturing and finished-product quality attributes. Do not generalize to CJC-1295 free base or any DAC-containing form.
CJC-1295 with DACCJC-1295 DAC free base	DAC free base	Regulatory-reviewed storage evidence	-20°C lyophilized; 4°C reconstituted	Evidence detail Storage / handling guidance CJC-1295 DAC free base is a fine white lyophilized powder stored at -20°C. Reconstituted material can be stored at 4°C; aliquoting is recommended to avoid repeated freeze/thaw. No duration or measured potency curve is provided for the reconstituted condition. Source class Regulatory briefing Source December 4, 2024 PCAC meeting -- CJC-1295 review Publication / identity U.S. FDA Year 2024 Identifiers Regulatory ID: FDA PCAC briefing PDF Directly measured No Exact-formulation match Yes Exact quote “The reconstituted peptide can be stored at 4°C.” Limitations No analytical curve, no duration for the 4°C reconstituted condition, no BAC-water identity, and no transfer to DAC acetate or DAC TFA -- FDA's broader review emphasizes insufficient public characterization and naming-convention uncertainty for several CJC forms. The DAC modification's albumin-binding/prolonged in-vivo half-life is biological/pharmacokinetic stability, not vial stability.
SomatropinRecombinant human growth hormone, rhGH, HGH	Reconstituted somatropin containing m-cresol; glass-vial controls	Direct stability test	2-8°C	Evidence detail What the evidence showed No significant purity or potency loss was observed through 28 days (days 0, 7, 14, 21, 28 measured) -- but this is a qualitative finding; the source does not publish the exact per-day percentages, so no numeric chart is built from this record. Container material affected turbidity: propylene-ethylene copolymer syringes became unacceptable after day 21, while polypropylene syringes supported stability to day 28. This is a strong public example that chemical stability and physical/container compatibility are separate questions. Source class Peer-reviewed analytical study Source Stability of somatropin stored in plastic syringes for 28 days Publication / identity American Journal of Health-System Pharmacy (Ray LR, Chen DA) Year 1998 Identifiers DOI: 10.1093/ajhp/55.14.1508PMID: 9676297 Analytical method HPLC purity, potency, m-cresol; pH, clarity/appearance, preservative effectiveness Directly measured Yes Exact-formulation match No Exact quote “did not show significant losses in purity or potency during the 28-day study.” Limitations Not every somatropin formulation; not a generic BAC-water study. Container material was the limiting factor in one tested syringe type, not chemical degradation.
SomatropinHuman growth hormone, hGH	Multiple excipient/pH systems (classic freeze-dried hGH formulation study)	Direct stability test	25°C and 40°C	Evidence detail What the evidence showed Chemical decomposition via methionine oxidation and asparagine deamidation, and aggregation, did occur during storage. Mannitol + glycine provided the greatest protection among the combinations tested. Solid-state pH before freeze-drying and salt/excipient choice materially affected stability. No specific percentage-vs-time values were reported for public ingestion. Source class Peer-reviewed analytical study Source The effects of formulation variables on the stability of freeze-dried human growth hormone Publication / identity Peer-reviewed pharmaceutical literature Year 1991 Identifiers PMID: 1871037 Analytical method HPLC and physical stability assessment Directly measured Yes Exact-formulation match No Exact quote “chemical decomposition via methionine oxidation and asparagine deamidation and aggregation did occur” Limitations Older exact formulation systems; not a modern product shelf-life curve. Strong mechanistic Learn-page evidence about lyophilized proteins, not a specific-product ingestion record.
SomatropinhGH	5.0 mg/mL somatropin + 45 mg/mL mannitol + 2.5 mg/mL phenol + 2.0 mg/mL polysorbate 20 + 2.5 mg/mL sodium citrate, pH 6.0	Direct stability test	2-8°C direct; 40°C stress comparison (Arrhenius modeling kept separate from directly measured data)	Evidence detail What the evidence showed Up to one year at 2-8°C: insignificant pH/color/appearance/protein-concentration change; no significant aggregation by SEC-HPLC. A lyophilized comparator was reconstituted with 1 mL Bacteriostatic Water for Injection (BWFI) in an agitation experiment, proving BAC-water use in that one experiment but not establishing a universal long-term BWFI shelf life. No specific percentage-vs-time values were published for public ingestion. Source class Patent analytical experiment Source Human growth hormone aqueous formulation Publication / identity U.S. Patent / Genentech (Inventors Barbara H. O'Connor, James Q. Oeswein) Year 1998 grant/publication Identifiers Patent: US5763394A Analytical method SEC-HPLC and anion-exchange chromatography; protein concentration/pH/appearance Directly measured Yes Exact-formulation match Yes Exact quote “showed no significant aggregation of the drug product” Limitations Proprietary buffered/preserved formulation; do not transfer to plain BAC water. 40°C Arrhenius-modeled projections must remain separate from the directly measured one-year data.
SomatropinHUMATROPE	HUMATROPE cartridge + supplied diluent	Approved-product formulation evidence	HUMATROPE is stable for up to 28 days when refrigerated (2-8°C) after reconstitution with its supplied diluent.	Evidence detail Storage / handling guidance HUMATROPE is stable for up to 28 days when refrigerated (2-8°C) after reconstitution with its supplied diluent. Source class Approved drug label Source HUMATROPE (somatropin) kit Publication / identity DailyMed / FDA (Eli Lilly labeling) Year Current labeling accessed 2026 Identifiers Regulatory ID: DailyMed setid a774e1ae-3997-49ee-8b0e-99a2b315d409 Directly measured No Exact-formulation match Yes Exact quote “stable for up to 28 days when refrigerated” Limitations Supplied metacresol/glycerin diluent is not generic BAC water. Do not transfer to GENOTROPIN or any other somatropin product's own handling period.
HCGHuman chorionic gonadotropin, recombinant hCG, rec-hCG	Recombinant hCG in phosphate/succinate systems; optimized experiments around pH 7 with sucrose, mannitol, glycine, NaCl and other excipients	Direct stability test	4°C, 25°C, 40°C, 50°C	Evidence detail What the evidence showed Sucrose/mannitol systems: 100% HPSEC monomer at 4°C through 12 weeks (Table 8). Mannitol formulation: no appreciable bioactivity decrease after 24 weeks at 4°C and 25°C. Elevated temperatures (40°C/50°C) showed progressive purity loss. Increased ionic strength and increased propylene glycol were detrimental; higher r-hCG concentration improved 50°C stability; NaCl performed worse than mannitol/sucrose under high-temperature stress. Only single flat/endpoint values were reported (not a declining multi-point series), so no numeric chart is built from this record. Source class Patent analytical experiment Source HCG liquid formulations Publication / identity U.S. Patent (Inventors Fabrizio Samaritani, Patrizia Natale; original assignee Applied Research Systems ARS Holding NV; current assignee Merck Serono SA) Year 2004 publication/grant Identifiers Patent: US6706681B1 Analytical method HPSEC purity/monomer; RP-HPLC (patent methods); European Pharmacopoeia bioassay Directly measured Yes Exact-formulation match Yes Exact quote “No appreciable bioactivity decrease was observed after 24 weeks at 4° and 25° C.” Limitations Does not transfer to urinary-derived lyophilized HCG or a generic BAC-water vial. Excellent demonstration of formulation/pH/excipient/concentration effects for recombinant liquid hCG specifically.
HCGNOVAREL, urinary-derived chorionic gonadotropin	NOVAREL 5,000 or 10,000 USP unit vial with supplied BAC-water diluent	Approved-product formulation evidence	NOVAREL, reconstituted with Bacteriostatic Water for Injection containing 0.9% benzyl alcohol, is refrigerated (2-8°C) and used within 30 days.	Evidence detail Storage / handling guidance NOVAREL, reconstituted with Bacteriostatic Water for Injection containing 0.9% benzyl alcohol, is refrigerated (2-8°C) and used within 30 days. Source class Approved drug label Source NOVAREL (gonadotrophin, chorionic) kit Publication / identity DailyMed / FDA Year Current labeling accessed 2026 Identifiers Regulatory ID: DailyMed setid ac6918ff-9dc3-40d9-8619-54b26e4bdfc8 Directly measured No Exact-formulation match Yes Exact quote “refrigerated and used within 30 days.” Limitations Not a measured degradation curve; urinary-derived exact product only. Differs from PREGNYL's 60-day label -- this is exactly why 'hCG' alone is not enough identity to determine handling.
HCGPREGNYL	PREGNYL 10,000 USP unit multi-dose vial + supplied solvent	Approved-product formulation evidence	PREGNYL, reconstituted with its supplied WFI/0.56% NaCl/0.9% benzyl alcohol diluent, is stable for use within 60 days when refrigerated (2-8°C).	Evidence detail Storage / handling guidance PREGNYL, reconstituted with its supplied WFI/0.56% NaCl/0.9% benzyl alcohol diluent, is stable for use within 60 days when refrigerated (2-8°C). Source class Approved drug label Source PREGNYL kit Publication / identity DailyMed / FDA (Organon labeling) Year Current label version published 2025, accessed 2026 Identifiers Regulatory ID: DailyMed setid 1e94155f-19be-4944-b197-be4edbb4faf9 Directly measured No Exact-formulation match Yes Exact quote “stable for 60 days when refrigerated.” Limitations Do not convert 60 days into a generic hCG potency curve; differs from NOVAREL's 30-day label -- same active molecule, different formulation/product, different validated handling period.
Thymosin Alpha-1Thymalfasin	Thymalfasin + mannitol + sorbitol; acetate-buffered system around pH 4 in preferred embodiments	Direct stability test	25°C (accelerated)	Evidence detail What the evidence showed Liquid thymalfasin formulation stability depended strongly on excipient system (mannitol/sorbitol) and pH; direct related-substance testing was performed under 25°C accelerated conditions over 6 months. Exact numeric table values were not exposed in the accessible source text, so no numeric chart is built from this record. Source class Patent analytical experiment Source Thymalfasin-containing medicinal composition and preparation method thereof Publication / identity CNIPA / China patent (granted family member CN102247319B) Year 2011 Identifiers Patent: CN102247319A Analytical method Chinese Pharmacopoeia related-substances method Directly measured Yes Exact-formulation match Yes Exact quote “adopt 25 ℃ of conditions, investigate 6 months as accelerated tests.” Limitations Accelerated 25°C study, not a 2-8°C reconstituted/BAC-water curve; exact numeric table values were not frozen from this source and must not be reconstructed.
Thymosin Alpha-1Thymalfasin	Thymalfasin + mannitol + sorbitol, preferred pH ~4 pre-lyophilization	Direct stability test	25°C (accelerated)	Evidence detail What the evidence showed Freeze-dried patent formulations were compared with prior formulations and marketed ZADAXIN under 25°C accelerated conditions. No exact numeric series was frozen from this source. Source class Patent analytical experiment Source Thymalfasin-containing medicinal composition and preparation method thereof Publication / identity CNIPA / China patent Year 2011 Identifiers Patent: CN102247319A Analytical method Chinese Pharmacopoeia injection/related-substances method Directly measured Yes Exact-formulation match Yes Limitations No exact numeric series frozen; not ordinary refrigerator storage.
Thymosin Alpha-1Thymalfasin, ZADAXIN	ZADAXIN sterile powder, 1.6 mg/1 mL	No matching direct degradation curve located	—	Context (not stability evidence) Thailand FDA's National Drug Information registry confirms ZADAXIN is registered as thymalfasin (thymosin alpha-1), sterile powder, strength 1.6 mg/1 mL, registration 1C 94/49(NB), manufactured by Patheon Italia. This confirms product identity and regulatory registration only -- the registry page does not itself provide post-reconstitution stability instructions, so this is NOT frozen as Type C stability evidence and must never be presented as a storage/handling period. Confirms product existence/identity only. No stability or handling data may be drawn from this record.
PT-141Bremelanotide, Bremelanotide acetate	Analytical/API bremelanotide acetate solution	Direct stability test	Multiple forced-stress conditions (acidic, basic, neutral hydrolytic, oxidative, thermal, photolytic)	Evidence detail What the evidence showed Lower degradation under acid than base; marked oxidative susceptibility; thermal and photolytic degradation also observed. Eight degradants were characterized; major pathways are deacetylation, peptide-bond hydrolysis, oxidation, and epimerization. Source class Peer-reviewed analytical study Source Comprehensive characterization of bremelanotide acetate and its degradants by LC-HRMS/MS and predicting epimerization through computational modelling Publication / identity Analytical Methods (Yuvaraaj VK, Sharma N, 2026) Year 2026 Identifiers DOI: 10.1039/D6AY01098APMID: 42485063 Analytical method Stability-indicating RP-HPLC + LC-HRMS/MS Directly measured Yes Exact-formulation match No Exact quote “showed significant susceptibility to oxidative conditions.” Limitations Forced degradation cannot be converted to 2-8°C or monthly storage loss. This is analytical/API bremelanotide acetate, not the VYLEESI commercial formulation.
PT-141Bremelanotide, VYLEESI	1.75 mg/0.3 mL bremelanotide; 2.5% glycerin in water; pH adjusted with HCl/NaOH	Regulatory-reviewed storage evidence	5°C (up to 30 months); 25°C/60% RH (up to 36 months); 30°C/65% RH (up to 12 months); 40°C/75% RH (up to 6 months)	Evidence detail What the evidence showed FDA's chemistry review documents VYLEESI registration stability studies at 5°C, 25°C/60% RH, 30°C/65% RH, and 40°C/75% RH, and explicitly states that adequate product stability was demonstrated at 5°C and 25°C/60% RH. Many numeric acceptance/result details are redacted from the public review, so no numeric chart is built from this record -- this is regulatory-reviewed evidence (Type B), not a fully exposed primary analytical dataset, even though the underlying registration measurements were real (directlyMeasured=true). Source class Regulatory briefing Source NDA 210557 VYLEESI Chemistry Review(s) Publication / identity U.S. FDA chemistry/quality review Year 2019 Identifiers Regulatory ID: NDA 210557 Analytical method Regulatory specification including assay, purity, and related substances (many numeric acceptance/result details are redacted from the public review) Directly measured Yes Exact-formulation match Yes Exact quote “demonstrated adequate product stability at 5°C and at 25°C/60% RH.” Limitations Public review redacts many numeric values; this is the proprietary finished VYLEESI formulation and cannot be generalized to lyophilized research PT-141 or bacteriostatic-water reconstitution.
PT-141Bremelanotide, VYLEESI	1.75 mg bremelanotide / 0.3 mL single-dose prefilled autoinjector; glycerin, water, sodium hydroxide, hydrochloric acid	Approved-product formulation evidence	Store at or below 25°C (77°F). Do not freeze. Protect from light.	Evidence detail Storage / handling guidance Store at or below 25°C (77°F). Do not freeze. Protect from light. Source class Approved drug label Source VYLEESI (bremelanotide) injection label Publication / identity DailyMed / FDA Year Current label effective 2025-11-13 Identifiers Regulatory ID: NDA210557 Directly measured No Exact-formulation match Yes Exact quote “Store at or below 25°C (77°F). Do not freeze. Protect from light.” Limitations Do not transfer to generic PT-141 research vials or bacteriostatic-water formulations. VYLEESI-specific only.
Melanotan IIMT-II, MT2	—	No matching direct degradation curve located	—	Context (not stability evidence) A peer-reviewed 2014 study developed validated LC-UV and LC-MS/MS methods to determine identity, content, and purity of Melanotan II products purchased online, finding substantial content variability and impurities. THIS IS NOT A STORAGE-STABILITY STUDY -- it is a single-timepoint analytical identity/purity characterization, not a longitudinal degradation curve. No acceptable peer-reviewed, regulatory, or citation-grade storage-stability experiment for Melanotan II was located in this audit; vendor refrigerated/frozen storage claims were reviewed and rejected as non-primary evidence. Confirms analytical identity/purity methods exist for Melanotan II; does not establish any storage stability, lyophilized stability, solution stability, or BAC-water period. Must never be presented as a stability record.
AOD-9604Tyr-hGH 177-191	AOD9604 HCl with PEG/Pearlitol and varying free-base arginine, dry capsule formulation	Direct stability test	25°C/60% RH; 40°C/75% RH; 60°C	Evidence detail What the evidence showed Increasing free-base arginine improved assay stability and reduced related-substance formation; a no-arginine formulation degraded completely within 3 months at 60°C. The patent attributes degradation to acid hydrolysis initiated by deamidation of a glutamine residue. Source class Patent analytical experiment Source Stabilisation of peptides with basic amino acids Publication / identity WIPO patent Year 2007 Identifiers Patent: WO2007033427A1 Analytical method HPLC assay + related substances Directly measured Yes Exact-formulation match Yes Exact quote “extending the room temperature stability from 3 months to more than 12 months.” Limitations Dry oral capsule formulation, not solution or injectable/BAC-water material; exact chart values are embedded in patent figures and were not frozen as exact numbers, so no numeric chart is built from this record. Do not transfer to generic HGH Fragment 176-191 without exact identity confirmation.
AOD-9604Tyr-hGH 177-191	AOD9604 + varying arginine / direct-compression excipients, dry tablet	Direct stability test	4°C, 25°C, 40°C	Evidence detail Source class Patent analytical experiment Source Stabilisation of peptides with basic amino acids Publication / identity WIPO patent Year 2007 Identifiers Patent: WO2007033427A1 Analytical method Two HPLC purity methods (TFA and TEAP) Directly measured Yes Exact-formulation match Yes Exact quote “Tablets were stored at 4, 25 and 40°C.” Limitations Dry tablet formulation only; does not establish reconstituted AOD9604 solution stability. Exact values are in patent figures and were not frozen as exact numbers -- no numeric chart is built from this record. Do not transfer to generic HGH Fragment 176-191 without exact identity confirmation.
IGF-1 LR3LONG R3 IGF-I, Long R3 IGF-I	Liquid format: 1 mg/mL in 100 mM acetic acid; also available lyophilized	No matching direct degradation curve located	—	Context (not stability evidence) Repligen, the manufacturer of LONG R3 IGF-I, states that lyophilized and unopened liquid material are stable for 5 years at 2-8°C, and that reconstituted aliquots in LoBind tubes are usable for 12 months at 2-8°C. This is exact-subject manufacturer technical guidance, not a public longitudinal stability-indicating dataset with timepoint assay/purity results, so it does not satisfy MitoCore's strict Type A rule; it is also not a regulatory review or approved-drug label, so it does not fit Type B/C. Native IGF-1/mecasermin stability must not be transferred to LONG R3 IGF-I. Manufacturer technical statement, not a published longitudinal stability study. Must not be presented as direct routine-condition analytical evidence.
IGF-1 LR3LONG R3 IGF-I	—	No matching direct degradation curve located	—	Context (not stability evidence) Repligen reports filter-dependent recovery losses for LONG R3 IGF-I: 0.2 µm PES 2%; 0.1 µm PES 5%; 0.2 µm PVDF <1%; 0.1 µm PVDF 6%; 0.2 µm cellulose acetate 11%. This is physical surface-adsorption/recovery-loss information, not time-dependent chemical degradation, and must never be labeled as a stability curve or potency-decay result. Adsorption/recovery loss is a distinct phenomenon from chemical degradation and must not be conflated with a stability curve.
Selank	Parent Selank (Thr-Lys-Pro-Arg-Pro-Gly-Pro), sealed lyophilizate vials	Direct stability test	35°C, standard humidity	Evidence detail Source class Patent analytical experiment Source New peptides and use thereof Publication / identity WIPO patent Year 2025 Identifiers Patent: WO2025037992A1 Analytical method HPLC-UV, Perkin Elmer 200 series, YMC Pack C4 column, 214 nm; monthly sampling Directly measured Yes Exact-formulation match Yes Exact quote “stored for 365 days at 35°C and standard humidity.” Limitations Accelerated dry-state experiment (35°C), not routine 2-8°C storage. Table E19 exact values were not exposed in the accessible patent text and must not be digitized or reconstructed. The same comparison patent also studies a chemically distinct N-acetyl/C-terminal-Arg-amide Selank derivative, which must remain a separate, distinct subject.
Selank	Parent Selank (Thr-Lys-Pro-Arg-Pro-Gly-Pro), aqueous solution	Direct stability test	40°C, 55% humidity	Evidence detail What the evidence showed Parent Selank solution was directly followed under 40°C accelerated storage while compared with a distinct stabilized derivative in the same patent. Source class Patent analytical experiment Source New peptides and use thereof Publication / identity WIPO patent Year 2025 Identifiers Patent: WO2025037992A1 Analytical method HPLC-UV, YMC Pack C4 column, 214 nm Directly measured Yes Exact-formulation match Yes Limitations Not 2-8°C storage; not BAC water. Table E21 exact cell values were not exposed in the accessible patent text and must not be reconstructed.

BPC-157

Free BPC-157

Direct stability test

Condition / Guidance: 40°C (accelerated aqueous stability condition)

Evidence detail

Source class: Patent analytical experiment
Source: European Patent EP 0 983 300 B1, Example 12
Publication / identity: European Patent Office (EPO)
Analytical method: HPLC purity/assay (%)
Directly measured: Yes
Exact-formulation match: Yes
Limitations: These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.

BPC-157

BPC-157 monoacetate

Direct stability test

Condition / Guidance: 40°C (accelerated aqueous stability condition)

Evidence detail

Source class: Patent analytical experiment
Source: European Patent EP 0 983 300 B1, Example 12
Publication / identity: European Patent Office (EPO)
Analytical method: HPLC purity/assay (%)
Directly measured: Yes
Exact-formulation match: Yes
Limitations: These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.

BPC-157

Sodium salt

Direct stability test

Condition / Guidance: 40°C (accelerated aqueous stability condition)

Evidence detail

Source class: Patent analytical experiment
Source: European Patent EP 0 983 300 B1, Example 12
Publication / identity: European Patent Office (EPO)
Analytical method: HPLC purity/assay (%)
Directly measured: Yes
Exact-formulation match: Yes
Limitations: These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.

BPC-157

Disodium salt

Direct stability test

Condition / Guidance: 40°C (accelerated aqueous stability condition)

Evidence detail

Source class: Patent analytical experiment
Source: European Patent EP 0 983 300 B1, Example 12
Publication / identity: European Patent Office (EPO)
Analytical method: HPLC purity/assay (%)
Directly measured: Yes
Exact-formulation match: Yes
Limitations: These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.

BPC-157

TRIS salt

Direct stability test

Condition / Guidance: 40°C (accelerated aqueous stability condition)

Evidence detail

Source class: Patent analytical experiment
Source: European Patent EP 0 983 300 B1, Example 12
Publication / identity: European Patent Office (EPO)
Analytical method: HPLC purity/assay (%)
Directly measured: Yes
Exact-formulation match: Yes
Limitations: These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.

BPC-157

diTRIS salt

Direct stability test

Condition / Guidance: 40°C (accelerated aqueous stability condition)

Evidence detail

Source class: Patent analytical experiment
Source: European Patent EP 0 983 300 B1, Example 12
Publication / identity: European Patent Office (EPO)
Analytical method: HPLC purity/assay (%)
Directly measured: Yes
Exact-formulation match: Yes
Limitations: These are specific aqueous salt/free-base forms tested at 40°C (an accelerated-stability condition). This is NOT a bacteriostatic-water refrigerator stability study, and these values must never be extrapolated to 2-8°C storage or to any other diluent, concentration, or container.

BPC-157

Free base (reconstituted)

Regulatory-reviewed storage evidence

Condition / Guidance: Reconstituted BPC-157 free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C.

Evidence detail

Storage / handling guidance: Reconstituted BPC-157 free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C.
Source class: Regulatory briefing
Source: FDA-reviewed regulatory briefing material (BPC-157 reconstituted storage guidance)
Publication / identity: FDA regulatory briefing
Directly measured: No
Exact-formulation match: Yes
Limitations: This is regulatory-reviewed storage guidance, not a measured percentage-vs-time degradation curve. No validated 120-day (or any) 2-8°C percentage-degradation curve was located for BPC-157 -- do not present this storage window as measured potency data.

TB-500

Free base (in solvent)

Regulatory-reviewed storage evidence

Condition / Guidance: TB-500 free base, in solvent, reportedly should be stored under sealed, moisture- and light-protected, nitrogen conditions for approximately 6 months at -80°C, or 1 month at -20°C.

Evidence detail

Storage / handling guidance: TB-500 free base, in solvent, reportedly should be stored under sealed, moisture- and light-protected, nitrogen conditions for approximately 6 months at -80°C, or 1 month at -20°C.
Source class: Regulatory briefing
Source: FDA-reviewed regulatory briefing material (TB-500 storage guidance)
Publication / identity: FDA regulatory briefing
Directly measured: No
Exact-formulation match: Yes
Limitations: No validated 2-8°C refrigerated percentage-vs-time degradation curve was identified for TB-500. These storage windows are regulatory-reviewed handling guidance, not measured potency data, and must not be presented as a percentage degradation curve.

KPV

Aqueous KPV

Regulatory-reviewed storage evidence

Condition / Guidance: Aqueous KPV was reported with storage guidance of approximately 6 months at -80°C, approximately 1 month at approximately -2°C, and approximately 1 week at 10°C.

Evidence detail

Storage / handling guidance: Aqueous KPV was reported with storage guidance of approximately 6 months at -80°C, approximately 1 month at approximately -2°C, and approximately 1 week at 10°C.
Source class: Regulatory briefing
Source: FDA-reviewed regulatory briefing material (KPV storage guidance)
Publication / identity: FDA regulatory briefing
Directly measured: No
Exact-formulation match: Yes
Limitations: This is storage guidance summarized in an FDA briefing, not a published percentage-vs-time degradation curve. No 120-day 2-8°C percentage curve was established for KPV.

MOTS-c

Reconstituted

Regulatory-reviewed storage evidence

Condition / Guidance: After reconstitution, MOTS-c reportedly stable at +4°C for approximately 2-7 days, or below -18°C for future use.

Evidence detail

Storage / handling guidance: After reconstitution, MOTS-c reportedly stable at +4°C for approximately 2-7 days, or below -18°C for future use.
Source class: Regulatory briefing
Source: FDA-reviewed regulatory briefing material (MOTS-c storage guidance)
Publication / identity: FDA regulatory briefing
Directly measured: No
Exact-formulation match: Yes
Limitations: No 120-day refrigerated potency curve was located for MOTS-c. This is storage guidance, not measured percentage-degradation data.

Semax

Reconstituted

Regulatory-reviewed storage evidence

Condition / Guidance: After reconstitution, Semax reportedly stable at +4°C for up to approximately 2-7 days.

Evidence detail

Storage / handling guidance: After reconstitution, Semax reportedly stable at +4°C for up to approximately 2-7 days.
Source class: Regulatory briefing
Source: FDA-reviewed regulatory briefing material (Semax storage guidance)
Publication / identity: FDA regulatory briefing
Directly measured: No
Exact-formulation match: Yes
Limitations: Long-term lyophilized storage guidance must not be interpreted as equivalent stability after reconstitution. No 120-day refrigerated potency curve was located for Semax.

Ipamorelin

Free base (reconstituted)

Regulatory-reviewed storage evidence

Condition / Guidance: Reconstituted ipamorelin free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C.

Evidence detail

Storage / handling guidance: Reconstituted ipamorelin free base reportedly stable approximately 2-3 weeks at 4°C, or 3-4 months at -20°C.
Source class: Regulatory briefing
Source: FDA-reviewed regulatory briefing material (ipamorelin storage guidance)
Publication / identity: FDA regulatory briefing
Directly measured: No
Exact-formulation match: Yes
Limitations: These reported storage windows are not a measured 120-day refrigerated percentage-degradation curve. The approved evidence also notes that stability can be affected by factors including pH, concentration, heat, excipients, impurities, and process conditions.

SS-31

(Elamipretide)

FORZINITY (elamipretide) approved aqueous formulation

Approved-product formulation evidence

Condition / Guidance: FORZINITY (elamipretide), an aqueous 80 mg/mL formulation, is stored at 2-8°C before use. After first opening, the vial may remain refrigerated or at room temperature; an opened vial is discarded after 8 days.

Evidence detail

Storage / handling guidance: FORZINITY (elamipretide), an aqueous 80 mg/mL formulation, is stored at 2-8°C before use. After first opening, the vial may remain refrigerated or at room temperature; an opened vial is discarded after 8 days.
Source class: Approved drug label
Source: FORZINITY (elamipretide) FDA-approved product labeling
Publication / identity: FDA-approved drug labeling / DailyMed
Directly measured: No
Exact-formulation match: Yes
Limitations: This approved formulation (FORZINITY, 80 mg/mL aqueous) is NOT equivalent to lyophilized SS-31 reconstituted with ordinary bacteriostatic water. Do not transfer this 8-day post-opening handling period to unrelated SS-31/elamipretide formulations or research-material vials.

Tesamorelin

EGRIFTA WR approved formulation, reconstituted with Bacteriostatic Water for Injection

Approved-product formulation evidence

Condition / Guidance: EGRIFTA WR, reconstituted with 1.3 mL Bacteriostatic Water for Injection, is stored at 20-25°C after mixing and discarded 7 days after mixing; the mixed formulation should not be refrigerated.

Evidence detail

Storage / handling guidance: EGRIFTA WR, reconstituted with 1.3 mL Bacteriostatic Water for Injection, is stored at 20-25°C after mixing and discarded 7 days after mixing; the mixed formulation should not be refrigerated.
Source class: Approved drug label
Source: EGRIFTA WR (tesamorelin) FDA-approved product labeling
Publication / identity: FDA-approved drug labeling / DailyMed
Directly measured: No
Exact-formulation match: Yes
Limitations: This is formulation-specific approved-product handling evidence for EGRIFTA WR. Do not infer that every tesamorelin research vial, or every bacteriostatic-water tesamorelin formulation, behaves identically to this exact approved product.

Retatrutide

(LY3437943)

Clinical study dosage formulation

No matching direct degradation curve located

Context (not stability evidence)

Clinical Phase 1 dosage formulations were reconstituted with sterile water or 0.9% saline -- this confirms clinical preparation media only. No time/temperature stability curve, no BAC-water data, and no validated shelf-life result exists for retatrutide in the approved evidence packet. Eli Lilly continued to describe retatrutide as investigational (not approved by any regulatory agency) as of July 2026.

No pharmaceutical storage stability study with an HPLC/purity/potency-vs-time curve was located for retatrutide. This record must never be presented as a refrigerated shelf life, a 30/60/90/120-day degradation percentage, or a BAC-water storage claim, and semaglutide/tirzepatide stability data must never be transferred to retatrutide.

Semaglutide

Water and buffers over varied pH/buffer strength (preformulation study)

Direct stability test

Condition / Guidance: 5, 25, 40, 55, 60, 80°C across study components

Evidence detail

What the evidence showed: Relative stability at pH 1.2 for one day at 25/40°C; increased degradation observed at pH 4.5-5.5 (near semaglutide's reported isoelectric region); stable for 3 h at 80°C in the reported condition. The publicly accessible abstract does not expose a complete 5°C percentage-vs-time table.
Source class: Peer-reviewed analytical study
Source: Influence of Buffering Capacity, pH, and Temperature on the Stability of Semaglutide: A Preformulation Study
Publication / identity: Journal of Peptide Science (Malgave A, Akbar S, Tiwari A, Hande S, Joseph A, Malayandi R, 2025)
Year: 2025
Identifiers: DOI: 10.1002/psc.70039PMID: 40635175
Analytical method: Two orthogonal stability-indicating RP-HPLC methods
Directly measured: Yes
Exact-formulation match: No
Exact quote: “A higher extent of degradation was observed between the pH of 4.5-5.5.”
Limitations: Does not establish BAC-water or generic refrigerated shelf life. Strong general semaglutide solution-stability record, but concentration/container were not exposed in the accessible abstract.

Semaglutide

Composition 1 (phenol-preserved, ~30 mg/mL)

Direct stability test

Condition / Guidance: 5°C (in-use)

Evidence detail

What the evidence showed: Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here.
Source class: Patent analytical experiment
Source: Article of Manufacture for Semaglutide Compositions
Publication / identity: U.S. patent application / Justia reproduction
Year: 2026 publication
Identifiers: Patent: US patent application 20260174835 (related WO2026083250A1)
Analytical method: Assay (potency) plus separately-tracked aggregate and related-substance measurements
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “maintaining specification compliance for up to three months (84 days).”
Limitations: These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.

Semaglutide

Composition 1 (phenol-preserved, ~30 mg/mL)

Direct stability test

Condition / Guidance: 30°C (in-use)

Evidence detail

What the evidence showed: Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here.
Source class: Patent analytical experiment
Source: Article of Manufacture for Semaglutide Compositions
Publication / identity: U.S. patent application / Justia reproduction
Year: 2026 publication
Identifiers: Patent: US patent application 20260174835 (related WO2026083250A1)
Analytical method: Assay (potency) plus separately-tracked aggregate and related-substance measurements
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “maintaining specification compliance for up to three months (84 days).”
Limitations: These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.

Semaglutide

Composition 3 (m-cresol-preserved, ~30 mg/mL)

Direct stability test

Condition / Guidance: 5°C (in-use)

Evidence detail

What the evidence showed: Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here.
Source class: Patent analytical experiment
Source: Article of Manufacture for Semaglutide Compositions
Publication / identity: U.S. patent application / Justia reproduction
Year: 2026 publication
Identifiers: Patent: US patent application 20260174835 (related WO2026083250A1)
Analytical method: Assay (potency) plus separately-tracked aggregate and related-substance measurements
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “maintaining specification compliance for up to three months (84 days).”
Limitations: These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.

Semaglutide

Composition 3 (m-cresol-preserved, ~30 mg/mL)

Direct stability test

Condition / Guidance: 30°C (in-use)

Evidence detail

What the evidence showed: Total aggregates and related substances (a separate measurement dimension from assay/potency) rose more at 30°C than at 5°C across days 28/56/84 in this same composition -- see the patent for exact aggregate/impurity values; not charted here.
Source class: Patent analytical experiment
Source: Article of Manufacture for Semaglutide Compositions
Publication / identity: U.S. patent application / Justia reproduction
Year: 2026 publication
Identifiers: Patent: US patent application 20260174835 (related WO2026083250A1)
Analytical method: Assay (potency) plus separately-tracked aggregate and related-substance measurements
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “maintaining specification compliance for up to three months (84 days).”
Limitations: These are genuine measured time-series data, but they belong to specific high-concentration, preserved (phenol- or m-cresol-containing) patent formulations at approximately 30 mg/mL -- NOT to plain bacteriostatic-water research-vial semaglutide. The same patent also reports total aggregates and related substances increasing more at 30°C than 5°C across days 28/56/84; those are a separate measurement dimension (not potency) and are not charted here.

Semaglutide

Analytical test solutions

Direct stability test

Condition / Guidance: 25°C; 60°C wet heat

Evidence detail

What the evidence showed: Forced-degradation endpoints (single measurement per stress protocol, not a time series): 12.00% degradation in 0.1 M HCl/25°C/10 min; 13.00% in 0.1 M NaOH/25°C/5 min; 14.80% with 10% H2O2/25°C/20 min; 12.35% after direct light/25°C/24 h; 12.60% after wet heat/60°C/60 min.
Source class: Peer-reviewed analytical study
Source: A multimodal HPLC stability indicating approach for the estimation of Semaglutide and Tirzepatide in bulk, pharmaceutical dosage forms, and rat plasma: a six-edged sustainability appraisal
Publication / identity: BMC Chemistry (2026)
Year: 2026
Identifiers: DOI: 10.1186/s13065-025-01716-7PMID: 41588418
Analytical method: HPLC-DAD stability-indicating approach (forced degradation)
Directly measured: Yes
Exact-formulation match: No
Exact quote: “the obtained degradation was 11.84% and 12.35% for TIR and SEM, respectively”
Limitations: These are deliberate forced-degradation stress endpoints, not routine storage. Not BAC water. A useful mechanism/stressor record, never shelf-life guidance.

Semaglutide

(OZEMPIC)

Current OZEMPIC multi-dose formulation: disodium phosphate dihydrate 1.42 mg/mL, propylene glycol 14 mg/mL, phenol 5.5 mg/mL, water

Approved-product formulation evidence

Condition / Guidance: OZEMPIC is stored at 2-8°C before use. After first use, the pen can be stored for 56 days at either 2-8°C or 15-30°C; protect from excessive heat/sunlight and do not freeze.

Evidence detail

Storage / handling guidance: OZEMPIC is stored at 2-8°C before use. After first use, the pen can be stored for 56 days at either 2-8°C or 15-30°C; protect from excessive heat/sunlight and do not freeze.
Source class: Approved drug label
Source: OZEMPIC (semaglutide) injection, solution
Publication / identity: DailyMed / FDA (Novo Nordisk labeling)
Year: Current labeling accessed 2026
Identifiers: Regulatory ID: DailyMed setid adec4fd2-6858-4c99-91d4-531f5f2a2d79
Directly measured: No
Exact-formulation match: Yes
Exact quote: “the pen can be stored for 56 days”
Limitations: Strong formulation-specific handling evidence. Does not transfer to research semaglutide or BAC-water vials.

Tirzepatide

Tirzepatide with NaCl tonicity agent and dibasic sodium phosphate (specific examples at 50 and 60 mg/mL)

Direct stability test

Condition / Guidance: 5°C, 25°C, 30°C

Evidence detail

What the evidence showed: 50 mg/mL + NaCl: >89% tirzepatide purity after 6 months at 30°C. 50/60 mg/mL formulations: acceptable purity supported for at least 6 months at 5°C and 25°C. SEC aggregation below 1% after at least 6 months at 5°C, and at or below 1% at 30°C, for tested strengths. Single reported endpoint (~6 months); no separate Day-0 baseline value was supplied, so this is not represented as a plotted chart.
Source class: Patent analytical experiment
Source: Tirzepatide compositions and use
Publication / identity: WIPO / Google Patents reproduction (Inventors Michael J. Koenig, Ken Kangyi Qian)
Year: 2024
Identifiers: Patent: WO2024006662A1; PCT/US2023/068925
Analytical method: Stability-indicating RP-HPLC for purity; SEC-HPLC/UV for high-molecular-weight species/aggregation
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “tirzepatide aggregation below 1 % for all strengths studied at 5°C.”
Limitations: Do not transfer to generic BAC-water/research vial. Broad two-year patent embodiment claims should not be treated as equivalent to the experimentally shown six-month results.

Tirzepatide

Analytical test solutions

Direct stability test

Condition / Guidance: 25°C; 60°C wet heat

Evidence detail

What the evidence showed: Forced-degradation endpoints (single measurement per stress protocol, not a time series): 16.90% degradation in 0.1 M HCl/25°C/10 min; 18.97% in 0.1 M NaOH/25°C/20 min; 15.91% with 10% H2O2/25°C/60 min; 11.84% after direct light/25°C/24 h; 17.90% after wet heat/60°C/90 min.
Source class: Peer-reviewed analytical study
Source: A multimodal HPLC stability indicating approach for the estimation of Semaglutide and Tirzepatide in bulk, pharmaceutical dosage forms, and rat plasma: a six-edged sustainability appraisal
Publication / identity: BMC Chemistry (2026)
Year: 2026
Identifiers: DOI: 10.1186/s13065-025-01716-7PMID: 41588418
Analytical method: HPLC-DAD stability-indicating approach (forced degradation)
Directly measured: Yes
Exact-formulation match: No
Limitations: Forced degradation only, not BAC water or routine storage.

Tirzepatide

(ZEPBOUND)

Current ZEPBOUND single-dose formulation

Approved-product formulation evidence

Condition / Guidance: ZEPBOUND is stored at 2-8°C; if needed, may be kept at or below 30°C for a total of up to 21 days for specified presentations. Protect from light; do not freeze.

Evidence detail

Storage / handling guidance: ZEPBOUND is stored at 2-8°C; if needed, may be kept at or below 30°C for a total of up to 21 days for specified presentations. Protect from light; do not freeze.
Source class: Approved drug label
Source: ZEPBOUND (tirzepatide) injection
Publication / identity: DailyMed / FDA (Eli Lilly labeling)
Year: Current labeling accessed 2026
Identifiers: Regulatory ID: DailyMed setid 487cd7e7-434c-4925-99fa-aa80b1cc776b
Directly measured: No
Exact-formulation match: Yes
Exact quote: “up to a total of 21 days.”
Limitations: Not generic tirzepatide stability; no BAC-water equivalence.

GHK-Cu

(Copper tripeptide-1, Glycyl-L-histidyl-L-lysine copper)

Water and pH 4.5-7.4 buffers; forced acid/base/oxidative conditions; carrier compatibility experiments (copper-complexed GHK-Cu, not uncomplexed GHK)

Direct stability test

Condition / Guidance: 60°C for aqueous/buffer and acid/base tests; ~22°C for oxidative test

Evidence detail

What the evidence showed: No degradation seen in water or pH 4.5-7.4 buffers over 2 weeks at 60°C. Forced-stress endpoints: 0.5 M HCl, 60°C, 1 week: 19.7% degraded (80.3% remaining). 0.5 M NaOH, 60°C, 24 h: 14.1% degraded (85.9% remaining). 0.5% H2O2, ~22°C, 1 h: 15.8% degraded. Degradation was hydrolytic cleavage under basic and oxidative stress, less so under acidic stress, with first-order profiles; carrier composition mattered (Span 60 niosomes compatible; negatively charged dicetyl phosphate reduced stability).
Source class: Peer-reviewed analytical study
Source: Physicochemical characterization of native glycyl-L-histidyl-L-lysine tripeptide for wound healing and anti-aging: a preformulation study for dermal delivery
Publication / identity: Pharmaceutical Development and Technology (Badenhorst T, Svirskis D, Wu Z)
Year: 2016 (Epub 2014)
Identifiers: DOI: 10.3109/10837450.2014.979944PMID: 25384620
Analytical method: Validated stability-indicating RP-HPLC; HPLC-MS
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “stable in water and in pH (4.5-7.4) buffers for at least two weeks at 60°C.”
Limitations: Not a 2-8°C shelf-life curve. Topical formulation-development context; no BAC-water data. Do not substitute uncomplexed-GHK evidence for GHK-Cu -- this record measures the copper complex explicitly.

CJC-1295 without DAC

(CJC-1295 free base)

Free base (bulk drug substance, crystalline solid)

Regulatory-reviewed storage evidence

Condition / Guidance: -20°C

Evidence detail

Storage / handling guidance: CJC-1295 free base, a crystalline solid, is stored at -20°C and is reported to remain stable for 4 or more years.
Source class: Regulatory briefing
Source: December 4, 2024 Pharmacy Compounding Advisory Committee meeting -- CJC-1295 review
Publication / identity: U.S. FDA
Year: 2024
Identifiers: Regulatory ID: FDA PCAC briefing PDF
Directly measured: No
Exact-formulation match: Yes
Exact quote: “stored at -20°C, and the BDS remains stable for 4 or more years.”
Limitations: FDA cites an underlying commercial source, not a peer-reviewed direct analytical curve. Do not transfer to CJC-1295 acetate, Modified GRF(1-29), Sermorelin, native GHRH fragments, or any DAC-containing form -- identity must remain separate.

CJC-1295 without DAC

(CJC-1295 acetate)

Acetate salt of CJC-1295 no-DAC free base

Regulatory-reviewed storage evidence

Condition / Guidance: 2-8°C sealed powder; -20°C powder; -80°C in solvent

Evidence detail

Storage / handling guidance: CJC-1295 acetate as a lyophilized powder is reported for sealed 2-8°C storage; reported up to 3 years at -20°C (powder); in solvent, reported stable up to 1 year when stored at -80°C.
Source class: Regulatory briefing
Source: December 4, 2024 PCAC meeting -- CJC-1295 review
Publication / identity: U.S. FDA (nominator CoA summary)
Year: 2024
Identifiers: Regulatory ID: FDA PCAC briefing PDF
Directly measured: No
Exact-formulation match: Yes
Exact quote: “in solvent is reported to remain stable up to 1 year when stored at -80°C.”
Limitations: CoA/vendor provenance, not a public analytical curve. FDA notes missing characterization (impurity/aggregate/endotoxin testing); stability is sensitive to manufacturing and finished-product quality attributes. Do not generalize to CJC-1295 free base or any DAC-containing form.

CJC-1295 with DAC

(CJC-1295 DAC free base)

DAC free base

Regulatory-reviewed storage evidence

Condition / Guidance: -20°C lyophilized; 4°C reconstituted

Evidence detail

Storage / handling guidance: CJC-1295 DAC free base is a fine white lyophilized powder stored at -20°C. Reconstituted material can be stored at 4°C; aliquoting is recommended to avoid repeated freeze/thaw. No duration or measured potency curve is provided for the reconstituted condition.
Source class: Regulatory briefing
Source: December 4, 2024 PCAC meeting -- CJC-1295 review
Publication / identity: U.S. FDA
Year: 2024
Identifiers: Regulatory ID: FDA PCAC briefing PDF
Directly measured: No
Exact-formulation match: Yes
Exact quote: “The reconstituted peptide can be stored at 4°C.”
Limitations: No analytical curve, no duration for the 4°C reconstituted condition, no BAC-water identity, and no transfer to DAC acetate or DAC TFA -- FDA's broader review emphasizes insufficient public characterization and naming-convention uncertainty for several CJC forms. The DAC modification's albumin-binding/prolonged in-vivo half-life is biological/pharmacokinetic stability, not vial stability.

Somatropin

(Recombinant human growth hormone, rhGH, HGH)

Reconstituted somatropin containing m-cresol; glass-vial controls

Direct stability test

Condition / Guidance: 2-8°C

Evidence detail

What the evidence showed: No significant purity or potency loss was observed through 28 days (days 0, 7, 14, 21, 28 measured) -- but this is a qualitative finding; the source does not publish the exact per-day percentages, so no numeric chart is built from this record. Container material affected turbidity: propylene-ethylene copolymer syringes became unacceptable after day 21, while polypropylene syringes supported stability to day 28. This is a strong public example that chemical stability and physical/container compatibility are separate questions.
Source class: Peer-reviewed analytical study
Source: Stability of somatropin stored in plastic syringes for 28 days
Publication / identity: American Journal of Health-System Pharmacy (Ray LR, Chen DA)
Year: 1998
Identifiers: DOI: 10.1093/ajhp/55.14.1508PMID: 9676297
Analytical method: HPLC purity, potency, m-cresol; pH, clarity/appearance, preservative effectiveness
Directly measured: Yes
Exact-formulation match: No
Exact quote: “did not show significant losses in purity or potency during the 28-day study.”
Limitations: Not every somatropin formulation; not a generic BAC-water study. Container material was the limiting factor in one tested syringe type, not chemical degradation.

Somatropin

(Human growth hormone, hGH)

Multiple excipient/pH systems (classic freeze-dried hGH formulation study)

Direct stability test

Condition / Guidance: 25°C and 40°C

Evidence detail

What the evidence showed: Chemical decomposition via methionine oxidation and asparagine deamidation, and aggregation, did occur during storage. Mannitol + glycine provided the greatest protection among the combinations tested. Solid-state pH before freeze-drying and salt/excipient choice materially affected stability. No specific percentage-vs-time values were reported for public ingestion.
Source class: Peer-reviewed analytical study
Source: The effects of formulation variables on the stability of freeze-dried human growth hormone
Publication / identity: Peer-reviewed pharmaceutical literature
Year: 1991
Identifiers: PMID: 1871037
Analytical method: HPLC and physical stability assessment
Directly measured: Yes
Exact-formulation match: No
Exact quote: “chemical decomposition via methionine oxidation and asparagine deamidation and aggregation did occur”
Limitations: Older exact formulation systems; not a modern product shelf-life curve. Strong mechanistic Learn-page evidence about lyophilized proteins, not a specific-product ingestion record.

Somatropin

(hGH)

5.0 mg/mL somatropin + 45 mg/mL mannitol + 2.5 mg/mL phenol + 2.0 mg/mL polysorbate 20 + 2.5 mg/mL sodium citrate, pH 6.0

Direct stability test

Condition / Guidance: 2-8°C direct; 40°C stress comparison (Arrhenius modeling kept separate from directly measured data)

Evidence detail

What the evidence showed: Up to one year at 2-8°C: insignificant pH/color/appearance/protein-concentration change; no significant aggregation by SEC-HPLC. A lyophilized comparator was reconstituted with 1 mL Bacteriostatic Water for Injection (BWFI) in an agitation experiment, proving BAC-water use in that one experiment but not establishing a universal long-term BWFI shelf life. No specific percentage-vs-time values were published for public ingestion.
Source class: Patent analytical experiment
Source: Human growth hormone aqueous formulation
Publication / identity: U.S. Patent / Genentech (Inventors Barbara H. O'Connor, James Q. Oeswein)
Year: 1998 grant/publication
Identifiers: Patent: US5763394A
Analytical method: SEC-HPLC and anion-exchange chromatography; protein concentration/pH/appearance
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “showed no significant aggregation of the drug product”
Limitations: Proprietary buffered/preserved formulation; do not transfer to plain BAC water. 40°C Arrhenius-modeled projections must remain separate from the directly measured one-year data.

Somatropin

(HUMATROPE)

HUMATROPE cartridge + supplied diluent

Approved-product formulation evidence

Condition / Guidance: HUMATROPE is stable for up to 28 days when refrigerated (2-8°C) after reconstitution with its supplied diluent.

Evidence detail

Storage / handling guidance: HUMATROPE is stable for up to 28 days when refrigerated (2-8°C) after reconstitution with its supplied diluent.
Source class: Approved drug label
Source: HUMATROPE (somatropin) kit
Publication / identity: DailyMed / FDA (Eli Lilly labeling)
Year: Current labeling accessed 2026
Identifiers: Regulatory ID: DailyMed setid a774e1ae-3997-49ee-8b0e-99a2b315d409
Directly measured: No
Exact-formulation match: Yes
Exact quote: “stable for up to 28 days when refrigerated”
Limitations: Supplied metacresol/glycerin diluent is not generic BAC water. Do not transfer to GENOTROPIN or any other somatropin product's own handling period.

HCG

(Human chorionic gonadotropin, recombinant hCG, rec-hCG)

Recombinant hCG in phosphate/succinate systems; optimized experiments around pH 7 with sucrose, mannitol, glycine, NaCl and other excipients

Direct stability test

Condition / Guidance: 4°C, 25°C, 40°C, 50°C

Evidence detail

What the evidence showed: Sucrose/mannitol systems: 100% HPSEC monomer at 4°C through 12 weeks (Table 8). Mannitol formulation: no appreciable bioactivity decrease after 24 weeks at 4°C and 25°C. Elevated temperatures (40°C/50°C) showed progressive purity loss. Increased ionic strength and increased propylene glycol were detrimental; higher r-hCG concentration improved 50°C stability; NaCl performed worse than mannitol/sucrose under high-temperature stress. Only single flat/endpoint values were reported (not a declining multi-point series), so no numeric chart is built from this record.
Source class: Patent analytical experiment
Source: HCG liquid formulations
Publication / identity: U.S. Patent (Inventors Fabrizio Samaritani, Patrizia Natale; original assignee Applied Research Systems ARS Holding NV; current assignee Merck Serono SA)
Year: 2004 publication/grant
Identifiers: Patent: US6706681B1
Analytical method: HPSEC purity/monomer; RP-HPLC (patent methods); European Pharmacopoeia bioassay
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “No appreciable bioactivity decrease was observed after 24 weeks at 4° and 25° C.”
Limitations: Does not transfer to urinary-derived lyophilized HCG or a generic BAC-water vial. Excellent demonstration of formulation/pH/excipient/concentration effects for recombinant liquid hCG specifically.

HCG

(NOVAREL, urinary-derived chorionic gonadotropin)

NOVAREL 5,000 or 10,000 USP unit vial with supplied BAC-water diluent

Approved-product formulation evidence

Condition / Guidance: NOVAREL, reconstituted with Bacteriostatic Water for Injection containing 0.9% benzyl alcohol, is refrigerated (2-8°C) and used within 30 days.

Evidence detail

Storage / handling guidance: NOVAREL, reconstituted with Bacteriostatic Water for Injection containing 0.9% benzyl alcohol, is refrigerated (2-8°C) and used within 30 days.
Source class: Approved drug label
Source: NOVAREL (gonadotrophin, chorionic) kit
Publication / identity: DailyMed / FDA
Year: Current labeling accessed 2026
Identifiers: Regulatory ID: DailyMed setid ac6918ff-9dc3-40d9-8619-54b26e4bdfc8
Directly measured: No
Exact-formulation match: Yes
Exact quote: “refrigerated and used within 30 days.”
Limitations: Not a measured degradation curve; urinary-derived exact product only. Differs from PREGNYL's 60-day label -- this is exactly why 'hCG' alone is not enough identity to determine handling.

HCG

(PREGNYL)

PREGNYL 10,000 USP unit multi-dose vial + supplied solvent

Approved-product formulation evidence

Condition / Guidance: PREGNYL, reconstituted with its supplied WFI/0.56% NaCl/0.9% benzyl alcohol diluent, is stable for use within 60 days when refrigerated (2-8°C).

Evidence detail

Storage / handling guidance: PREGNYL, reconstituted with its supplied WFI/0.56% NaCl/0.9% benzyl alcohol diluent, is stable for use within 60 days when refrigerated (2-8°C).
Source class: Approved drug label
Source: PREGNYL kit
Publication / identity: DailyMed / FDA (Organon labeling)
Year: Current label version published 2025, accessed 2026
Identifiers: Regulatory ID: DailyMed setid 1e94155f-19be-4944-b197-be4edbb4faf9
Directly measured: No
Exact-formulation match: Yes
Exact quote: “stable for 60 days when refrigerated.”
Limitations: Do not convert 60 days into a generic hCG potency curve; differs from NOVAREL's 30-day label -- same active molecule, different formulation/product, different validated handling period.

Thymosin Alpha-1

(Thymalfasin)

Thymalfasin + mannitol + sorbitol; acetate-buffered system around pH 4 in preferred embodiments

Direct stability test

Condition / Guidance: 25°C (accelerated)

Evidence detail

What the evidence showed: Liquid thymalfasin formulation stability depended strongly on excipient system (mannitol/sorbitol) and pH; direct related-substance testing was performed under 25°C accelerated conditions over 6 months. Exact numeric table values were not exposed in the accessible source text, so no numeric chart is built from this record.
Source class: Patent analytical experiment
Source: Thymalfasin-containing medicinal composition and preparation method thereof
Publication / identity: CNIPA / China patent (granted family member CN102247319B)
Year: 2011
Identifiers: Patent: CN102247319A
Analytical method: Chinese Pharmacopoeia related-substances method
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “adopt 25 ℃ of conditions, investigate 6 months as accelerated tests.”
Limitations: Accelerated 25°C study, not a 2-8°C reconstituted/BAC-water curve; exact numeric table values were not frozen from this source and must not be reconstructed.

Thymosin Alpha-1

(Thymalfasin)

Thymalfasin + mannitol + sorbitol, preferred pH ~4 pre-lyophilization

Direct stability test

Condition / Guidance: 25°C (accelerated)

Evidence detail

What the evidence showed: Freeze-dried patent formulations were compared with prior formulations and marketed ZADAXIN under 25°C accelerated conditions. No exact numeric series was frozen from this source.
Source class: Patent analytical experiment
Source: Thymalfasin-containing medicinal composition and preparation method thereof
Publication / identity: CNIPA / China patent
Year: 2011
Identifiers: Patent: CN102247319A
Analytical method: Chinese Pharmacopoeia injection/related-substances method
Directly measured: Yes
Exact-formulation match: Yes
Limitations: No exact numeric series frozen; not ordinary refrigerator storage.

Thymosin Alpha-1

(Thymalfasin, ZADAXIN)

ZADAXIN sterile powder, 1.6 mg/1 mL

No matching direct degradation curve located

Context (not stability evidence)

Thailand FDA's National Drug Information registry confirms ZADAXIN is registered as thymalfasin (thymosin alpha-1), sterile powder, strength 1.6 mg/1 mL, registration 1C 94/49(NB), manufactured by Patheon Italia. This confirms product identity and regulatory registration only -- the registry page does not itself provide post-reconstitution stability instructions, so this is NOT frozen as Type C stability evidence and must never be presented as a storage/handling period.

Confirms product existence/identity only. No stability or handling data may be drawn from this record.

PT-141

(Bremelanotide, Bremelanotide acetate)

Analytical/API bremelanotide acetate solution

Direct stability test

Condition / Guidance: Multiple forced-stress conditions (acidic, basic, neutral hydrolytic, oxidative, thermal, photolytic)

Evidence detail

What the evidence showed: Lower degradation under acid than base; marked oxidative susceptibility; thermal and photolytic degradation also observed. Eight degradants were characterized; major pathways are deacetylation, peptide-bond hydrolysis, oxidation, and epimerization.
Source class: Peer-reviewed analytical study
Source: Comprehensive characterization of bremelanotide acetate and its degradants by LC-HRMS/MS and predicting epimerization through computational modelling
Publication / identity: Analytical Methods (Yuvaraaj VK, Sharma N, 2026)
Year: 2026
Identifiers: DOI: 10.1039/D6AY01098APMID: 42485063
Analytical method: Stability-indicating RP-HPLC + LC-HRMS/MS
Directly measured: Yes
Exact-formulation match: No
Exact quote: “showed significant susceptibility to oxidative conditions.”
Limitations: Forced degradation cannot be converted to 2-8°C or monthly storage loss. This is analytical/API bremelanotide acetate, not the VYLEESI commercial formulation.

PT-141

(Bremelanotide, VYLEESI)

1.75 mg/0.3 mL bremelanotide; 2.5% glycerin in water; pH adjusted with HCl/NaOH

Regulatory-reviewed storage evidence

Condition / Guidance: 5°C (up to 30 months); 25°C/60% RH (up to 36 months); 30°C/65% RH (up to 12 months); 40°C/75% RH (up to 6 months)

Evidence detail

What the evidence showed: FDA's chemistry review documents VYLEESI registration stability studies at 5°C, 25°C/60% RH, 30°C/65% RH, and 40°C/75% RH, and explicitly states that adequate product stability was demonstrated at 5°C and 25°C/60% RH. Many numeric acceptance/result details are redacted from the public review, so no numeric chart is built from this record -- this is regulatory-reviewed evidence (Type B), not a fully exposed primary analytical dataset, even though the underlying registration measurements were real (directlyMeasured=true).
Source class: Regulatory briefing
Source: NDA 210557 VYLEESI Chemistry Review(s)
Publication / identity: U.S. FDA chemistry/quality review
Year: 2019
Identifiers: Regulatory ID: NDA 210557
Analytical method: Regulatory specification including assay, purity, and related substances (many numeric acceptance/result details are redacted from the public review)
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “demonstrated adequate product stability at 5°C and at 25°C/60% RH.”
Limitations: Public review redacts many numeric values; this is the proprietary finished VYLEESI formulation and cannot be generalized to lyophilized research PT-141 or bacteriostatic-water reconstitution.

PT-141

(Bremelanotide, VYLEESI)

1.75 mg bremelanotide / 0.3 mL single-dose prefilled autoinjector; glycerin, water, sodium hydroxide, hydrochloric acid

Approved-product formulation evidence

Condition / Guidance: Store at or below 25°C (77°F). Do not freeze. Protect from light.

Evidence detail

Storage / handling guidance: Store at or below 25°C (77°F). Do not freeze. Protect from light.
Source class: Approved drug label
Source: VYLEESI (bremelanotide) injection label
Publication / identity: DailyMed / FDA
Year: Current label effective 2025-11-13
Identifiers: Regulatory ID: NDA210557
Directly measured: No
Exact-formulation match: Yes
Exact quote: “Store at or below 25°C (77°F). Do not freeze. Protect from light.”
Limitations: Do not transfer to generic PT-141 research vials or bacteriostatic-water formulations. VYLEESI-specific only.

Melanotan II

(MT-II, MT2)

No matching direct degradation curve located

Context (not stability evidence)

A peer-reviewed 2014 study developed validated LC-UV and LC-MS/MS methods to determine identity, content, and purity of Melanotan II products purchased online, finding substantial content variability and impurities. THIS IS NOT A STORAGE-STABILITY STUDY -- it is a single-timepoint analytical identity/purity characterization, not a longitudinal degradation curve. No acceptable peer-reviewed, regulatory, or citation-grade storage-stability experiment for Melanotan II was located in this audit; vendor refrigerated/frozen storage claims were reviewed and rejected as non-primary evidence.

Confirms analytical identity/purity methods exist for Melanotan II; does not establish any storage stability, lyophilized stability, solution stability, or BAC-water period. Must never be presented as a stability record.

AOD-9604

(Tyr-hGH 177-191)

AOD9604 HCl with PEG/Pearlitol and varying free-base arginine, dry capsule formulation

Direct stability test

Condition / Guidance: 25°C/60% RH; 40°C/75% RH; 60°C

Evidence detail

What the evidence showed: Increasing free-base arginine improved assay stability and reduced related-substance formation; a no-arginine formulation degraded completely within 3 months at 60°C. The patent attributes degradation to acid hydrolysis initiated by deamidation of a glutamine residue.
Source class: Patent analytical experiment
Source: Stabilisation of peptides with basic amino acids
Publication / identity: WIPO patent
Year: 2007
Identifiers: Patent: WO2007033427A1
Analytical method: HPLC assay + related substances
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “extending the room temperature stability from 3 months to more than 12 months.”
Limitations: Dry oral capsule formulation, not solution or injectable/BAC-water material; exact chart values are embedded in patent figures and were not frozen as exact numbers, so no numeric chart is built from this record. Do not transfer to generic HGH Fragment 176-191 without exact identity confirmation.

AOD-9604

(Tyr-hGH 177-191)

AOD9604 + varying arginine / direct-compression excipients, dry tablet

Direct stability test

Condition / Guidance: 4°C, 25°C, 40°C

Evidence detail

Source class: Patent analytical experiment
Source: Stabilisation of peptides with basic amino acids
Publication / identity: WIPO patent
Year: 2007
Identifiers: Patent: WO2007033427A1
Analytical method: Two HPLC purity methods (TFA and TEAP)
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “Tablets were stored at 4, 25 and 40°C.”
Limitations: Dry tablet formulation only; does not establish reconstituted AOD9604 solution stability. Exact values are in patent figures and were not frozen as exact numbers -- no numeric chart is built from this record. Do not transfer to generic HGH Fragment 176-191 without exact identity confirmation.

IGF-1 LR3

(LONG R3 IGF-I, Long R3 IGF-I)

Liquid format: 1 mg/mL in 100 mM acetic acid; also available lyophilized

No matching direct degradation curve located

Context (not stability evidence)

Repligen, the manufacturer of LONG R3 IGF-I, states that lyophilized and unopened liquid material are stable for 5 years at 2-8°C, and that reconstituted aliquots in LoBind tubes are usable for 12 months at 2-8°C. This is exact-subject manufacturer technical guidance, not a public longitudinal stability-indicating dataset with timepoint assay/purity results, so it does not satisfy MitoCore's strict Type A rule; it is also not a regulatory review or approved-drug label, so it does not fit Type B/C. Native IGF-1/mecasermin stability must not be transferred to LONG R3 IGF-I.

Manufacturer technical statement, not a published longitudinal stability study. Must not be presented as direct routine-condition analytical evidence.

IGF-1 LR3

(LONG R3 IGF-I)

No matching direct degradation curve located

Context (not stability evidence)

Repligen reports filter-dependent recovery losses for LONG R3 IGF-I: 0.2 µm PES 2%; 0.1 µm PES 5%; 0.2 µm PVDF <1%; 0.1 µm PVDF 6%; 0.2 µm cellulose acetate 11%. This is physical surface-adsorption/recovery-loss information, not time-dependent chemical degradation, and must never be labeled as a stability curve or potency-decay result.

Adsorption/recovery loss is a distinct phenomenon from chemical degradation and must not be conflated with a stability curve.

Selank

Parent Selank (Thr-Lys-Pro-Arg-Pro-Gly-Pro), sealed lyophilizate vials

Direct stability test

Condition / Guidance: 35°C, standard humidity

Evidence detail

Source class: Patent analytical experiment
Source: New peptides and use thereof
Publication / identity: WIPO patent
Year: 2025
Identifiers: Patent: WO2025037992A1
Analytical method: HPLC-UV, Perkin Elmer 200 series, YMC Pack C4 column, 214 nm; monthly sampling
Directly measured: Yes
Exact-formulation match: Yes
Exact quote: “stored for 365 days at 35°C and standard humidity.”
Limitations: Accelerated dry-state experiment (35°C), not routine 2-8°C storage. Table E19 exact values were not exposed in the accessible patent text and must not be digitized or reconstructed. The same comparison patent also studies a chemically distinct N-acetyl/C-terminal-Arg-amide Selank derivative, which must remain a separate, distinct subject.

Selank

Parent Selank (Thr-Lys-Pro-Arg-Pro-Gly-Pro), aqueous solution

Direct stability test

Condition / Guidance: 40°C, 55% humidity

Evidence detail

What the evidence showed: Parent Selank solution was directly followed under 40°C accelerated storage while compared with a distinct stabilized derivative in the same patent.
Source class: Patent analytical experiment
Source: New peptides and use thereof
Publication / identity: WIPO patent
Year: 2025
Identifiers: Patent: WO2025037992A1
Analytical method: HPLC-UV, YMC Pack C4 column, 214 nm
Directly measured: Yes
Exact-formulation match: Yes
Limitations: Not 2-8°C storage; not BAC water. Table E21 exact cell values were not exposed in the accessible patent text and must not be reconstructed.

Key Takeaways

Stability evidence is peptide- and formulation-specific, not a single number per peptide name.
Chemical, physical, and microbiological/in-use stability are three separate questions.
Accelerated (elevated-temperature) data is not the same measurement as real-time refrigerator data.
A validated product's storage/discard instructions describe that exact approved product, not every research-material vial sold under the same name.
Where no approved direct evidence exists yet, this page says so explicitly rather than estimating.

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Peptide Stability & Degradation Evidence

Three Kinds of Stability

Why Peptides Degrade

Lyophilized vs. Reconstituted

Accelerated Stability Testing

BPC-157: HPLC purity across six salt/free-base forms

HPLC purity by form, Day 0 / 76 / 120

Semaglutide: patent in-use assay by preserved formulation

Semaglutide assay (%) by composition, Day 0 / 28 / 56 / 84

Wave 1 Evidence Coverage Matrix

What Wave 1 Teaches About Stability

Quick Reference

Stability Evidence Library

Key Takeaways

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