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Tag: simulated light pharma degradation]

Use of Simulated Sunlight in Photostability Chambers

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Use of Simulated Sunlight in Photostability Chambers Harnessing Simulated Sunlight in Photostability Chambers for Drug Stability Testing Photostability testing is a regulatory requirement for drug development, mandated under ICH Q1B guidelines. This process ensures that light exposure does not compromise the safety, efficacy, or quality of pharmaceutical products. To replicate real-world light conditions, photostability chambers…

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  • Prepare Expiry Justification Reports to Support Regulatory Queries and Renewals

    Understanding the Tip: What are expiry justification reports: Expiry justification reports are formal documents that summarize the rationale behind an assigned shelf life.
    They compile… Read more

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