1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …

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1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT ANDVALIDATIONChange to read:INTRODUCTIONPurposeThis 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. For productscontaining more than a single active ingredient, develop and validate the method(s) for each active ingredient.

INTRODUCTION Purpose This chapter provides a comprehensive approach covering items to consider for developing and validating dissolution procedures and the accompanying analytical procedures. It addresses the use of automation throughout the test and provides guidance and criteria for validation.

  Introduction, Chapter