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Pharma Stability: Insights, Guidelines, and Expertise

Tag: moisture-induced degradation

Impact of Moisture Sensitivity in Accelerated Stability Testing

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Impact of Moisture Sensitivity in Accelerated Stability Testing Understanding the Impact of Moisture Sensitivity in Accelerated Stability Testing Moisture is one of the most influential environmental factors affecting pharmaceutical product stability. When conducting accelerated stability testing, moisture-sensitive drugs and formulations are at increased risk of degradation, leading to erroneous shelf-life projections and regulatory concerns. This…

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  • Prepare Expiry Justification Reports to Support Regulatory Queries and Renewals

    Understanding the Tip: What are expiry justification reports: Expiry justification reports are formal documents that summarize the rationale behind an assigned shelf life.
    They compile… Read more

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