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1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …

1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT ANDVALIDATIONC hange to read:INTRODUCTIONP urposeThis chapter provides a comprehensive approach covering items to consider for developing and validating dissolutionprocedures and the accompanying analytical procedures. It addresses the use of automation throughout the test and providesguidance and criteria for validation. It also addresses the treatment of the data generated and the interpretation of acceptancecriteria for immediate- and modified-release solid oral dosage chapter addresses the DEVELOPMENT and validation of DISSOLUTION procedures, with a focus on solid oral dosage of the concepts presented, however, may be applicable to other dosage forms and routes of administration.

5.4 Precision 5.4.1 Repeatability of Analysis 5.4.2 Intermediate Precision/Ruggedness 5.4.3 Reproducibility 5.5 Robustness 5.6 Stability of Standard and Sample Solutions ... (such as dynamic solubility, potentiometric titration, or turbidity measurement methods). (USP …

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latam-edu.usp.org

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