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In FDA's 2026 review of BPC-157, the certificates of analysis submitted listed purity but no results for specified impurities, aggregates, microbial load or bacterial endotoxins, and FDA's literature search found that most such certificates report purity alone.[1]
What a certificate of analysis is for
Under federal compounding law, a bulk drug substance used by a 503A pharmacy must come from an FDA-registered establishment and be accompanied by a valid certificate of analysis [1]. FDA says certificates can help it identify and characterize a substance, and that a compounder should use the impurities a certificate identifies to judge safety and quality risks [1].
SoftMaxx AI does not grade or name any seller or testing lab, and nothing on this page is advice on where to get a product.
What the certificates FDA reviewed listed
| Test | On the BPC-157 certificates FDA reviewed | What FDA says about it |
|---|---|---|
| Appearance, identification, solubility | Listed | — |
| Purity | Listed: one gave a limit of at least 95% and a result of 97.8%; the other gave only a result, 98.34% | Most certificates FDA found in the literature report purity alone [1] |
| Related substances (largest single impurity, total impurities) | One certificate: limits of 3.0% and 5.0%, results of 1.1% and 2.2% | The impurities were not identified, so the impurity profile is unclear [1] |
| Specified (named) impurities | Not reported | Synthesis can leave impurities so similar to the peptide that they may be hard to identify and measure without sophisticated methods |
| Aggregates | Not reported | Can provoke immune responses; finding them may take several methods, such as size exclusion chromatography |
| Bioburden (microbial count) | Not reported | A critical quality consideration for injectable products |
| Bacterial endotoxins | Not reported | With sterility and foreign particulates, a safety factor for injection products |
| Sterility | Not among the results FDA listed | A safety factor for injection products [1] |
| Salt form matching the substance named | No: both were for the acetate salt, while the nominations' identifiers matched the free base; FDA says it is unclear which form the nominators meant | Different salts sold under one common name can mean a patient gets a different substance than was ordered [1] |
All rows: FDA's July 2026 briefing on BPC-157 [1]. The percentages are test results on the material, not doses.
- Regulator document Both certificates submitted to FDA for BPC-157 listed appearance, identification, purity, solubility, related substances (unspecified impurity) and acetic acid content, with no results for specified impurities, aggregates, bioburden or bacterial endotoxins. FDA's own literature search found that most BPC-157 certificates contain only purity testing.[1]
How identity and purity are tested
One of the lab studies on this page used liquid chromatography to separate and measure a peptide and its impurities, and mass spectrometry to confirm what the peptide is [2]. That 2015 study of Melanotan II vials confirmed identity by liquid chromatography with tandem mass spectrometry, and measured content and impurities by liquid chromatography with UV detection, validated against guidelines used for authorized medicines [2].
What lab tests of products sold outside pharmacies found
Two lab studies in our checked reference set compared peptide products sold outside pharmacies with what their labels claimed [2] [3]. Both tested small numbers of products, so they show that mislabeling happens, not how often.
- Melanotan II vials bought from three online shops, each labelled with the same amount, held between about 43% and 88% of the stated amount; vials from two of the shops also contained 4.1% to 5.9% unknown impurities [2].
- Of 17 black-market products sold as follistatin, only 9 contained follistatin; some of the others contained different growth-promoting peptides [3].
- Regulator document FDA warns that counterfeit Ozempic could contain the wrong ingredients, or too little, too much or no active ingredient at all, and says it knows of fraudulent compounded semaglutide and tirzepatide whose labels carry false information.[4]
- Regulator document Health Canada warns that unauthorized peptide drugs may contain too much, too little or none of the active ingredient, unlisted or unknown ingredients, or contaminants such as solvents, heavy metals, particles, bacteria, fungi or endotoxins, and may be poorly or incorrectly labelled.[5]
What a certificate cannot tell you
We found no study that measured how often certificates of analysis for peptides are falsified.
- Regulator document A purity figure does not say what the rest of the material is. In FDA's review, one certificate gave a total for impurities without identifying them, so FDA called the impurity profile unclear and said it could not rule out immune reactions from unidentified impurities and aggregates.[1]
- Regulator document Contamination is a separate question from purity. For injection products, FDA names sterility, bacterial endotoxins and foreign particulates as safety factors, and the certificates it reviewed had no endotoxin or microbial results.[1]
- Regulator document FDA notes that significant amounts of aggregates can form in formulated products, especially during storage or under stress. A certificate dated before a product ships cannot report on that.[1]
- Regulator document A certificate is not an approval. FDA says compounded drugs are not FDA approved, so it does not review them for safety, effectiveness or quality before they are marketed, and for BPC-157 it says it lacks sufficient information to know whether the drug would cause harm in people.[4][6]
- Expert review A 2026 review describes consumer use of peptides outside clinical supervision as experimentation with products of uncertain identity, purity, potency, sterility and safety.[7]
Questions FDA's review raises about any certificate
- Does it name the exact substance, including the salt form, and does that match the product's label? FDA found certificates for a different salt form than the one the nominations' identifiers matched [1].
- Does it name the impurities, or only give a total? Unnamed impurities left FDA unable to judge the impurity profile [1].
- For anything meant for injection, does it report sterility, bacterial endotoxins and particulates? FDA calls these safety factors for injection products [1].
- Does it say anything about aggregates? FDA links them to immune reactions [1].
A yes to every question still would not make an unapproved product approved or tested in people: FDA says it does not review compounded drugs for safety, effectiveness or quality before they are marketed [4]. For how storage after testing matters, see how long reconstituted peptides last; for symptoms that need a clinician, see peptide red flags.
Report a side effect
If something went wrong after using any product, tell a clinician and report it. Reports are how regulators find contaminated or mislabeled products.
- FDA MedWatch (United States)
- Canada Vigilance Program (Canada)
Common questions
What does a peptide certificate of analysis show?
Regulator document Only the tests its issuer reports. The BPC-157 certificates FDA reviewed listed appearance, identification, purity, solubility, related substances and acetic acid content, with no results for specified impurities, aggregates, microbial load or bacterial endotoxins.[1]
Does 99% purity mean a peptide is safe?
Regulator document No. In FDA's review, purity results did not identify the impurities, and endotoxins, microbial load and aggregates were separate tests the certificates did not report. FDA could not rule out immune reactions from unidentified impurities and aggregates in BPC-157.[1]
Does a COA show endotoxin levels?
Regulator document Only if endotoxin testing was done and reported. The BPC-157 certificates FDA reviewed had no bacterial endotoxin results, and FDA counts endotoxins as a safety factor for injection products.[1]
Can a certificate of analysis be faked?
Regulator document We found no study that measured how often peptide certificates are falsified. FDA reports fraudulent compounded semaglutide and tirzepatide whose labels carry false information, and Health Canada warns that unauthorized products may be poorly or incorrectly labelled.[4][5]
References
Every reference below was matched to its PubMed or DOI record (title checked) before publication. "Verified" means the paper exists and is the one named; what it supports is stated next to each claim.
July 23-24, 2026, Meeting of the Pharmacy Compounding Advisory Committee – FDA Briefing Document for BPC-157-Related Bulk Drug Substances (BPC-157 (free base) and BPC-157 acetate)
SourceIdentification and characterization by LC-UV-MS/MS of melanotan II skin-tanning products sold illegally on the Internet.
PubMed 24771717 DOIDetection of black market follistatin 344.
PubMed 31758732 DOIFDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
SourceThink twice before injecting peptides bought online: unauthorized products can seriously harm you (Health Canada advisory; lists KPV)
SourceCertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
SourceUnregulated Peptide Use in the Age of Biohacking: Digital Promotion, Gray-Market Access, and Emerging Public Health Risks.
PubMed 42437212 DOI
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