Certificate of analysis (CoA)
A certificate of analysis is a document from a supplier or testing lab reporting the identity, purity, potency, and other test results for a specific lot of a bulk drug substance or finished preparation — the paper trail that shows a compounded medication was made from what it claims to be made from.
- Issued per lot by supplier or testing lab
- Reports identity, purity, potency
- Required for API sourcing due diligence
- Ask for one during pharmacy vetting
Where CoAs appear in a compounded program
Twice. First, the compounding pharmacy should hold a CoA for every lot of bulk active pharmaceutical ingredient it uses, from an FDA-registered supplier. Second, for sterile preparations and higher-risk products, the pharmacy may run or commission release testing — potency, sterility, endotoxin — and produce a CoA for the finished lot.
Why programs should ask for them
The single most common gap in pharmacy vetting is API sourcing. A pharmacy that cannot produce a CoA for its bulk substance, or whose CoA comes from an unregistered supplier, is a program risk regardless of how good its pricing is. Asking for a sample CoA during vetting takes five minutes and answers the question.
- Confirms the API supplier is FDA-registered
- Shows identity and purity of the substance
- For finished lots: potency, sterility, endotoxin results
- Should be retrievable by lot on request
Compliance handled, so you can build
Lithos runs the clinicians, pharmacies, and 50-state rules behind your care program — one API.
Frequently asked questions
Should a telehealth program review certificates of analysis?
Yes, at least during pharmacy vetting and periodically after. The program is not the manufacturer, but it chooses the pharmacy, and API sourcing is where quality problems originate.
What should a CoA include?
The substance or product name, lot number, test methods, results against specifications, the testing lab, and a date. For finished sterile preparations, sterility and endotoxin results.
Do 503B facilities issue CoAs?
Lot-level release testing with documented results is standard under cGMP, so 503B facilities routinely provide them. 503A pharmacies vary; ask.