• Period after opening date of 12 months written on the side of an open jar of pharmaceutical product determined by stability testing
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Sub-Part I - Laboratory Controls

8.7 - Laboratory Controls - Stability Testing

$29.00
$29.00
Tax included.

Developmental stability, performed during the development of a new drug product, must be used to determine appropriate storage conditions, specification acceptance criteria, and expiration dates. Routine stability, performed maximum annually once the drug is marketed, must be used to confirm these parameters on a periodic basis.

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Period after opening date of 12 months written on the side of an open jar of pharmaceutical product determined by stability testing