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MOTS-c Compounding Pharmacy: How to Read a Certificate of Analysis

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9 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • Molecule / MOTS-c, a 16-amino-acid mitochondrial peptide
  • Molecular weight / about 2174.6 g/mol [1]
  • Monograph specific to MOTS-c / none; FDA found no USP or NF monograph [1]
  • Salt forms / free base and acetate treated as different bulk substances [1]
  • COA requirement / valid COA from an FDA-registered manufacturer [3]
  • Human data / no human exposure data, no animal toxicity studies [1]
  • Injection concern / immunogenicity from aggregation and peptide impurities [4]

What a certificate can and cannot prove

FDA's compounding rules say a bulk drug substance must come with a valid certificate of analysis and must have been made by an establishment registered with FDA [3]. HHS's draft enforcement-discretion policy, filed in October 2026, names MOTS-c acetate for subcutaneous or intramuscular injection and lists a certificate of analysis from an FDA-registered manufacturer among its conditions; it is a draft, establishes no rights and is not binding on HHS [5][6].

A certificate cannot make the peptide well characterized. MOTS-c is not FDA-approved and is not a component of an approved drug [1]. Compounded drugs in general are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they reach patients [5].

Identity: the number you can check

MOTS-c is a 16-amino-acid peptide (Met-Arg-Trp-Gln-Glu-Met-Gly-Tyr-Ile-Phe-Tyr-Pro-Arg-Lys-Leu-Arg) of about 2174.6 g/mol [1][2]. That figure is the value a reader can hold against a published one. FDA treats the free base and the acetate as different bulk substances, so the document should state which one the lot is. FDA also notes that 'MOTS-c' is a common name rather than an official drug name [1].

Purity, impurities and endotoxin

FDA's review recorded no impurity, aggregate or endotoxin data for MOTS-c [1].

This matters for an injectable. FDA notes that injectable peptides may pose an immunogenicity risk from aggregation and peptide-related impurities [4], and its MOTS-c review states that no immunogenicity data exist [1]. A clean chromatogram does not supply that missing data, and a claim that a lot meets a USP specification for MOTS-c needs scrutiny.

What to check on the document

  • Is the manufacturer named and registered with FDA? The bulk substance is required to come from a registered establishment [3].
  • Is the salt form stated? The free base and the acetate are separate substances [1].
  • Does the lot identified on the certificate match the lot identified for the material?
  • Are the tests performed and the limits used both listed, rather than a bare pass?

The regulatory record behind the document

MOTS-c appears in none of the three categories on FDA's list for state-licensed pharmacies and is absent from the outsourcing facility list, so FDA's category 1 no-action policy does not cover it [7][8][3]. FDA staff recommended in July 2026 against adding either form to the compounding list. The advisory committee voted the other way that month, and that vote is advice only [1][9].

Frequently asked questions

Does MOTS-c have a USP monograph?
No MOTS-c-specific one. FDA's July 2026 review found no USP or National Formulary monograph for MOTS-c, no listing in the European or Japanese pharmacopeias and no EMA-authorised product [1].
What should a MOTS-c certificate of analysis show?
An identity consistent with 16 amino acids and about 2174.6 g/mol, the salt form (free base or acetate), the lot, an FDA-registered manufacturer, and the tests performed with the limits used [1][2][3].
Is there an official endotoxin or impurity limit for MOTS-c?
Not one that FDA identified. Its review found no impurity, aggregate or endotoxin data for MOTS-c [1].
Does a passing certificate mean MOTS-c is safe?
No. FDA found no clinical study in which MOTS-c was given to a human, no human exposure data by any route and no animal toxicity studies, so its safety in people is unknown [1].
Is MOTS-c on FDA's compounding lists?
No. It appears in none of the three categories on FDA's list for state-licensed pharmacies and is absent from the outsourcing facility list [7][8][3]. The July 2026 advisory committee vote in its favour is non-binding, and HHS's October 2026 enforcement-discretion policy is a draft limited to the acetate form given by injection [9][5].

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. Lee C, Zeng J, Drew BG, Sallam T, Martin-Montalvo A, Wan J, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443-54. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance
  3. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA
  4. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  5. Official web page. Official web page
  6. Official web page. Official web page
  7. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  8. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  9. U.S. Food and Drug Administration. U.S. Food and Drug Administration
Evidence overview for MOTS-c Compounding Pharmacy: How to Read a Certificate of Analysis