HPLC检查非残溶杂质分析方法验证的实例解析

Examples Analysis of Validation of Analytical Methods for Testing the Non-Residual Solvents Impurities by HPLC

目的:对于用HPLC检查非残留溶剂杂质的分析方法验证问题,通过实例解析进行探讨,以便更好地操作和指导工作。方法:通过具体介绍,解析实例,更直观、全面地阐述分析方法验证的要求。结果与结论:分析方法验证,无论在质量保证工作,还是在药品注册活动中,都非常重要,企业必须结合具体情况,提出适宜方案,并且认真贯彻实施。

Objective: To discuss the validation of analytical methods for testing the non-residual solvents impurities by HPLC by examples analysis so as to operate and guide the works much better. Method: With introducing and analyzing the example specifically, the validation by using analysis method was described overall and directly. Result and conclusion: The validation of analysis methods is vital important not only in the quality control but also in the medicine registration. It's necessary to introduce the suitable program in conjunction with the concrete situation and then to carry out seriously.