starting material for drug substance
- Guideline or reference source
- ICHQ3A Impurities in new drug substances
- Definition
- A material used in the synthesis of a new drug substance that is incorporated as an element into the structure of an intermediate and/or of the new drug substance. Starting materials are normally commercially available and of defined chemical and physical properties and structure.
- Broader Term
- starting material
- Related Term
- api starting material
- raw material
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