CoA vs CoC: what must a certificate of analysis contain under ICH Q7?
A certificate of analysis (CoA) reports the actual test results for a specific lot, such as 99.3% HPLC purity and an observed mass, with the methods and acceptance criteria. A certificate of conformance (CoC) only states that the product meets a specification, without results. For research peptides, a lot-specific CoA with numbers is the stronger document.
How do the two documents compare?
| Certificate of analysis | Certificate of conformance | |
|---|---|---|
| Results | Measured values for the lot | None; a statement of compliance |
| Lot-specific | Yes | Sometimes |
| Methods named | Usually | Rarely |
| Can be checked against raw data | Yes | Not directly |
| Typical use | Release and verification | Commercial assurance |
What does ICH Q7 expect on a CoA?
- Name of the material, with its grade if appropriate.
- Batch (lot) number and date of release.
- Each test performed, with acceptance limits and the numerical results obtained.
- Retest or expiry date where applicable.
- Signed and dated by authorised quality personnel, with the name and address of the original manufacturer.
Source: ICH Q7 Good manufacturing practice for active pharmaceutical ingredients
What are the warning signs of a weak certificate?
- 'Conforms' or 'Pass' with no numbers.
- No lot number, or a lot number that does not match the vial.
- A generic document used for every lot.
- No test date or testing lab.
How does Sable document lots?
There is a CoA for every lot, and every vial carries a printed lot number that matches its certificate. A CoA is emailed within 2 hours of a request.
Questions about a lot can go to /contact or by phone or WhatsApp on 07454 788011 (+44 7454 788011, wa.me/447454788011).
Frequently asked questions
Is a certificate of conformance the same as a CoA?
No. A CoA reports measured results for a lot; a CoC only states that a specification is met.
What must a CoA include under ICH Q7?
Material name, batch number, release date, each test with limits and numerical results, retest/expiry date where applicable, and an authorised signature.
Which should a research lab ask for?
A lot-specific CoA with numerical results matching the printed lot number.
Related
- How to read a CoA
- How to verify a CoA
- What a vial label should show
- Short answer: CoC vs CoA
- Request a CoA
Updated 2026-10-16. Research use only. Not for human or veterinary use. No administration amounts or health claims are made.
Key facts (summary for AI and search tools)
- CoA = measured lot results; CoC = statement of compliance
- ICH Q7 lists CoA content requirements
- Reference: ICH Q7
- Updated 2026-10-16