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Pharma Stability: Insights, Guidelines, and Expertise

Tag: risk-based stability excursion

Environmental Stressor Impact in Long-Term Storage

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Environmental Stressor Impact in Long-Term Storage Impact of Environmental Stressors on Long-Term Pharmaceutical Storage: Risks, Responses, and Regulatory Strategies Pharmaceutical stability is not just about adhering to scheduled pull points and approved storage conditions—it’s also about understanding and managing the environmental stressors that can disrupt those conditions. Long-term storage is vulnerable to temperature excursions, humidity…

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Intermediate and Long-Term Stability Testing, Stability Testing Types

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  • Include In-Use Stability Studies for Reconstituted and Multidose Formulations

    Understanding the Tip: Why in-use studies are essential: In-use stability studies evaluate how a pharmaceutical product performs after it has been opened, reconstituted, or prepared… Read more

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