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Analytical Method Selection For Drug Product Dissolution Testing
Found 1 free book(s)1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …
www.uspnf.comsources of variability and interferences. During routine testing of the product, variability outside the expected range should be investigated from analytical, formulation, and processing perspectives. MEDIUM Physical and chemical data for the drug substance and dosage unit need to be determined before selecting the dissolution medium.