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Pharma Stability: Insights, Guidelines, and Expertise

Tag: regulatory compliance validation

Analytical Method Validation Requirements in Stability Studies

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Analytical Method Validation Requirements in Stability Studies Analytical Method Validation for Stability Studies: Regulatory and Technical Requirements Accurate and reliable analytical data is the backbone of stability studies in the pharmaceutical industry. To ensure data integrity and regulatory compliance, analytical methods used to assess drug stability must be rigorously validated. This article outlines the core…

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  • Fully Validate Stability-Indicating Methods Before Use in Studies

    Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API)… Read more

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