USP-1092-溶出度试验的开发和验证(中英文对照版).docxVIP

INTRODUCTION .、八 、- 刖言 Purpose 目的 The Dissoluti on Procedure: Developme ntand Validati on 1092 provides a comprehe nsive approach coveri ng items to con siderfor develop ing and validat ing dissoluti on procedures and the accompa nyingan alytical procedures. It addresses the use of automati on throughout the testa nd provides guidance and criteria for validation. It also addresses thetreatme nt of the data gen erated and the in terpretati on of accepta nce criteriafor immediate- and modified-release solid oral dosage forms. 溶出实验：开发和验证（1092）指导原则提供了在溶出度方法开发和验证过程中 以及采用相应分析方法时需要考虑的因素。本指导原则贯穿溶出度实验的