stability test
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions
- Narrower Term
- stability testing container closure system
- Related Term
- accelerated testing
- matrixing
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