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Pharma Stability: Insights, Guidelines, and Expertise

Tag: impurity peak quantification photostability

Interpreting Photostability Chromatograms for Degradation Profiling

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Interpreting Photostability Chromatograms for Degradation Profiling How to Interpret Photostability Chromatograms for Effective Degradation Profiling Chromatographic analysis plays a pivotal role in photostability testing, enabling the identification, quantification, and profiling of degradation products formed upon exposure to light. Interpreting photostability chromatograms is critical for assessing the stability of pharmaceutical substances and ensuring compliance with ICH…

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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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