degradation product
- Guideline or reference source
- ICHQ5C stability testing of biotechnological/biological products
- ICHQ6A Specifications: new chemical drug substances and products
- Definition
- A molecule resulting from a chemical change in the drug molecule brought about over time and/or by the action of e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system.
- Used For
- decomposition product
- degradant
- Broader Term
- constituent
- Narrower Term
- degradation product, impurity
- Related Term
- degradation profile
- forced degradation testing studies
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