AOD-9604
Regulatory status
Placed in Category 2 of FDA's 503A bulk drug substances list — significant safety risks identified. Not eligible for 503A compounding. Available to verified facilities for research and manufacturing use.
Summary
AOD-9604 is a synthetic sixteen-residue fragment corresponding to the C-terminal region of human growth hormone, carrying a disulfide bridge. The oxidation step that forms the bridge is the main quality variable across manufacturers.
Reduced and mis-paired disulfide forms are not always resolved by the standard reversed-phase method, so we ask for a peptide map or a non-reduced and reduced comparison rather than a single purity figure.
Typical related substances
Typical related substances are the reduced open-chain form, intermolecular disulfide dimers and oxidised methionine variants.
Regulatory note
Category 2 of the FDA 503A bulk drug substances list. Not eligible for 503A compounding.
Regulatory status shown is our current understanding and is not legal advice. Each facility is responsible for confirming eligibility for its own licence type before purchase.