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  • <Expiration dates from stability studies on two cartons of different medicine products on a white table with some yellow, brown and blue oval tablets in front of them. Credit> 2141323401 © Kasarp Studio | Shutterstock.com
    2141323401 © Kasarp Studio | Shutterstock.com
  • <Some round white tablets that have failed stability studies with a suspected brown fungi or yeast growth. Credit> 169194947 © Thidarat Petprasom | Dreamstime.com
    169194947 © Thidarat Petprasom | Dreamstime.com
  • <Stability analyst placing stability samples in the refrigerator for studies in cold temperatures to replicate shipping. Credit> AdobeStock_500284461
    AdobeStock_500284461
  • <Large walk in, real time, 25 degree C and 60% relative humidity stability room, with two rows of twelve shelves full of medicine samples on either side of a central walkway one meter wide. Credit> Freepik
    Freepik
  • <Controlled temperature and humidity chamber for stability testing being used to calibrate probes placed on the middle stainless steel grid shelf. Credit> 142294667 © Audrius Merfeldas | Dreamstime.com
    142294667 © Audrius Merfeldas | Dreamstime.com
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8.7 - Laboratory Controls - Stability Testing

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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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<Expiration dates from stability studies on two cartons of different medicine products on a white table with some yellow, brown and blue oval tablets in front of them. Credit> 2141323401 © Kasarp Studio | Shutterstock.com
$26.00 USD
$26.00 USD