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Pharma Stability: Insights, Guidelines, and Expertise

Tag: stability data justification

Justification for Testing Beyond Proposed Expiry Period

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Justification for Testing Beyond Proposed Expiry Period Justifying Stability Testing Beyond the Proposed Expiry Period: Scientific and Regulatory Perspectives Stability studies are designed to define the period during which a pharmaceutical product maintains its identity, strength, quality, and purity. However, there are situations where it becomes necessary—or even strategic—to conduct stability testing beyond the originally…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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