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Pharma Stability: Insights, Guidelines, and Expertise

Tag: photostability testing CTD

Designing Photostability Testing Protocols for Regulatory Submissions

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Designing Photostability Testing Protocols for Regulatory Submissions How to Develop Regulatory-Compliant Photostability Testing Protocols in Pharmaceuticals Photostability testing is an essential component of stability evaluation for pharmaceutical drug substances and products. As mandated by ICH Q1B, photostability studies must assess the potential effects of light exposure to ensure product quality, safety, and efficacy. Designing a…

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  • Maintain Backup Stability Chambers to Prevent Data Loss in Case of Failure

    Understanding the Tip: Why backup chambers are essential: Stability chambers are critical infrastructure in pharmaceutical QA.
    A sudden malfunction—due to power failure, temperature controller breakdown,… Read more

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