The deliverable
What a certificate of analysis contains
One certificate per sample, reporting potency against the label claim alongside identity and purity, plus the concentration you will actually be dosing.
Illustrative example. Not an issued certificate.
Every field on the certificate
Specimen
- Specimen identifier
- Received
- Reported
As declared by you
- Compound
- Lot
- Label claim (mg)
- Reconstitution volume (mL)
Measured
- Identity
- Purity (%)
- Potency (mg and % of label)
- Concentration (mg/mL at your stated volume)
Verdict
- Within spec, below label, above label, or inconclusive
Method
- Technique
- Reference standard
- LOD and LOQ
- Instrument
- Signatory
Concentration is derived and printed, not left for you to work out. A 10 mg label reconstituted with 2 mL should give 5.0 mg/mL; at 72% potency it gives 3.6 mg/mL. That is the number a dose is drawn against.
What the certificate does not claim
It attests to the sample submitted. It does not certify a vendor, a lot beyond the one tested, or future production, and it makes no representation as to safety or suitability.