API Starting Material

A raw material, intermediate, or API used in producing an API and incorporated as a significant structural fragment into the structure of the API.

Related sections

ICH Q7 Glossary ICH Q7 §§7–11

Related terms

Active Pharmaceutical Ingredient (API) / Drug Substance85 casesStarting Material15 casesIntermediate109 cases

Real inspection findings

See 1 findings that mention this term

Source

ICH Q7, §20 Glossary, API Starting Material