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Pharma Stability: Insights, Guidelines, and Expertise

Tag: reactive oxygen species stability

Stress Testing for Autooxidation in API Development

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Stress Testing for Autooxidation in API Development Implementing Stress Testing for Autooxidation in API Development: A Practical Guide Autooxidation is a critical degradation pathway that can compromise the stability, efficacy, and safety of active pharmaceutical ingredients (APIs). As part of a comprehensive stability evaluation, stress testing for oxidative degradation provides essential insight into a molecule’s…

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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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