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Pharma Stability: Insights, Guidelines, and Expertise

Tag: WHO PQ stability strategies

Using ICH Q1A and Q1B Together in Long-Term Stability Planning

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Using ICH Q1A and Q1B Together in Long-Term Stability Planning Using ICH Q1A and Q1B Guidelines Together in Long-Term Pharmaceutical Stability Planning Long-term pharmaceutical stability studies must go beyond monitoring chemical degradation at controlled temperature and humidity—they must also evaluate the impact of light exposure. The integration of ICH Q1A (R2) and ICH Q1B provides…

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  • Protect Photostability Samples from Secondary Light Exposure During Testing

    Understanding the Tip: What is secondary light exposure and why it matters: Secondary light exposure refers to unintended light contact that occurs outside of a… Read more

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