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Tag: photodegradation real case studies

Stability Failures from Improper Light Protection: Real-World Case Studies

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Stability Failures from Improper Light Protection: Real-World Case Studies Lessons from Photostability Failures: Real-World Case Studies on Inadequate Light Protection In pharmaceutical development and post-market surveillance, improper light protection is a recurring cause of stability failures. Despite clear guidance from ICH Q1B, regulatory authorities continue to report cases of product degradation due to underestimating light…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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