1092USP39THEDISSOLUTIONPROCEDUREDEVELOPMENTANDVALIDATION(中英).docVIP

1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION INTRODUCTION Purpose 目的 The dissolution procedure: development and validation 1092 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. It also addresses the treatment of the data generated and the interpretation of acceptance criteria for immediate- and modified-release solid oral dosage forms. 溶出度试验的开发和验证1092目的是为溶出度的测定提供了全面的开