degradation product, impurity
- Guideline or reference source
- ICHQ3B Impurities in new drug products
- Definition
- An impurity resulting from a chemical change in the drug substance brought about during manufacture and/or storage of the new drug product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system.
- Broader Term
- degradation product
- Narrower Term
- identified degradation product
- specified degradation product
- unidentified degradation product
- unspecified degradation product
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