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Pharma Stability: Insights, Guidelines, and Expertise

Stability Studies – API

The Future of API Stability Testing: Trends and Innovations

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The Future of API Stability Testing: Trends and Innovations The Future of API Stability Testing: Trends and Innovations Introduction to API Stability Testing API stability testing is a cornerstone of pharmaceutical development, ensuring that Active Pharmaceutical Ingredients (APIs) maintain their quality, efficacy, and safety throughout their lifecycle. As the pharmaceutical industry evolves, advancements in technology…

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Stability Studies - API

Developing Comprehensive SOPs for API Stability Studies

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Developing Comprehensive SOPs for API Stability Studies How to Develop Comprehensive SOPs for API Stability Studies Introduction to SOPs in API Stability Studies Standard Operating Procedures (SOPs) are critical documents that ensure consistency, accuracy, and regulatory compliance in API stability studies. These procedures provide detailed instructions for conducting stability testing, analyzing data, and managing deviations,…

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  • Start Stability Protocol Design with ICH Q1A(R2) Guidance

    Tip: Always refer to ICH Q1A(R2) before designing a stability protocol to align with global regulatory expectations.
    Understanding the Tip: Why protocol design matters: Stability protocols define how long a pharmaceutical product remains safe and effective… Read more

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