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Tag: CTD Requirements

Fully Validate Stability-Indicating Methods Before Use in Studies

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Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API) without interference from degradation products, excipients, or impurities. Its primary role is to detect changes in the chemical profile of the drug substance or product during stability studies, making it…

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  • Fully Validate Stability-Indicating Methods Before Use in Studies

    Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API)… Read more

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