impurity
- Guideline or reference source
- ICHQ3A Impurities in new drug substances
- Definition
- (1) Any component of the new drug substance which is not the chemical entity defined as the new drug substance. (2) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product.
- Broader Term
- constituent
- Narrower Term
- extraneous contaminant
- extraneous substance
- mutagenic impurity
- potential impurity
- process-related impurities
- product-related impurities
- specified impurity
- unspecified impurity
- Related Term
- acceptable limit
- contaminants
- contamination
- control treshold
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