AOD-9604 Compounding Pharmacy: How to Read a Certificate of Analysis

What a certificate of analysis covers

A certificate of analysis reports the tests a laboratory ran on one specific lot and the results it got. Which tests appear, which methods were used and what limits apply differ from one certificate to the next.

FDA's page says state-licensed physicians and pharmacists that compound may only use bulk drug substances accompanied by a valid certificate of analysis and manufactured by an establishment registered with FDA under section 510 of the FD&C Act [7]. That requirement applies to the bulk ingredient a pharmacy buys, not the finished vial it prepares. A certificate for the raw peptide cannot show that the vial dispensed to a patient was sterile or free of endotoxin, and it may not report either test at all. Check which product the certificate identifies, which lot it names, and which tests and results it actually shows.

A reported result needs a stated limit to be interpreted, since the same figure can pass one specification and fail another. AOD-9604 also has no approved product to compare a lot against: it is a 16-amino-acid fragment of human growth hormone, amino acids 177 to 191 plus an N-terminal tyrosine, developed as an anti-obesity candidate that never reached approval [2][3][4].

What FDA says about compounded AOD-9604

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in its table of substances previously in category 2 whose nominators withdrew them. Its stated concerns: compounded AOD-9604 may pose significant immunogenicity risk for certain routes of administration from peptide impurities and characterization problems; FDA has identified no or only limited safety information; and serious adverse events may be associated with AOD-9604, though causality is not clear. Removal from that category was not a finding that it is safe [1].

AOD-9604 appears in none of the three categories on FDA's interim list for state-licensed pharmacies and physicians, and it is not on FDA's list for outsourcing facilities [8][9][7]. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they reach patients [10]. Claims that AOD-9604 is GRAS trace back to the developer, not to FDA: FDA's GRAS Notice Inventory contains no AOD-9604 notice [6].

Questions worth asking about the sheet in front of you

• Does the certificate cover the bulk peptide the pharmacy bought, or the finished vial?
• Which lot does it identify, and does that lot number match the vial?
• Which laboratory ran the tests, and is it independent of the seller?
• Which tests and results does it report, which methods were used, and against what stated limit?

Those questions show how much testing was documented, not whether the peptide works or is safe in people.