shelf life
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.
- Used For
- expiration dating period
- Narrower Term
- shelf life after dilution or reconstitution according to directions
- shelf life after first opening the immediate packaging
- shelf life after incorporation into meal or pelleted feed
- shelf life from manufacturing time
- shelf life from the activity reference time stated on the label
- shelf life in unit-dose dispensing
- shelf life of the medicinal product as packaged for sale
- Related Term
- expiry date
- shelf life acceptance criteria
- specification, shelf life
- storage conditions
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