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Tag: oxidative stability dossier expectations

Global Regulatory Expectations for Oxidative Stability Testing

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Global Regulatory Expectations for Oxidative Stability Testing Oxidative Stability Testing in Pharmaceuticals: Meeting Global Regulatory Expectations Oxidative degradation is one of the most common pathways through which pharmaceutical products lose potency, generate impurities, or undergo chemical instability. Regulatory authorities worldwide mandate oxidative stability testing to ensure safety, efficacy, and shelf-life accuracy of drug substances and…

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