CoA, MSDS and technical files: what to request with every API order
PERAMERA · 3 November 2026
Ordering an active pharmaceutical ingredient is only half the job. The other half is the paperwork that proves what you received, keeps your people safe and supports your product registration. Here is what to ask for, and why.
1. Certificate of Analysis (CoA)
The CoA is issued for a specific lot. It lists each test in the specification, the acceptance limit and the result for that lot, and it is signed by the manufacturer's quality unit. Check that the lot number on the CoA matches the label on every drum, and that the tests match the specification you agreed, for example a pharmacopoeia monograph such as USP, BP or EP.
PERAMERA supplies a CoA with every lot as standard.
2. Safety Data Sheet (SDS or MSDS)
The SDS describes hazards, safe handling, storage, spill response and transport information. Your warehouse and production teams need it before the material arrives, not after.
3. Specification and technical data sheet
The specification defines what "good" looks like for the material: identity, assay, impurities, particle size, water content and other tests. Agree on it before you order so that the CoA can be compared against it.
4. Manufacturer documents for registration
For many registrations you will need information about the manufacturer and its process, such as a Drug Master File (DMF) reference, a Certificate of Suitability (CEP) or a GMP certificate. Availability depends on the manufacturer and the molecule, so ask early. We help organise what the manufacturer can provide.
5. Shipping documents
Commercial invoice, packing list, certificate of origin and the bill of lading or air waybill are needed for customs clearance. Ask your supplier which Incoterm applies, so you know who arranges each document.
A simple checklist
- CoA for each lot, lot number matching the labels
- SDS in the language your team uses
- Agreed specification or pharmacopoeia reference
- Manufacturer documents needed for your dossier
- Shipping documents for your Incoterm
Need documents for a specific molecule? Send us your request and our team will tell you what is available before you order.