Pharmaceuticals and APIs

Buying pharmaceutical materials is different from buying industrial chemicals. For an API that will go into a medicine, the manufacturing site must work to good manufacturing practice, usually following ICH Q7, and the product must meet a pharmacopoeia monograph such as the USP, Ph. Eur., BP, IP or JP where one exists. Regulators in the market of sale expect supporting documents, typically a drug master file, a certificate of suitability from the EDQM, or an equivalent dossier, along with impurity profiles and stability data.

When you post a request, state whether you need the material for research, for development batches or for commercial production, which pharmacopoeia and regulatory documents you require, the batch size and any particle size or polymorph specification. Suppliers on CompoundList list their own grades and documents, and a substance page showing reference data is not proof that any supplier holds a licence. Controlled drugs and their precursors can only be traded between licensed parties, so read the controlled substances policy before you ask for them.