盐酸头孢他美酯质量标准残留溶剂检查方法的标准化研究

Standardization on establishment of residual solvent determination method for quality control requirements of cefetamet pivoxil hydrochloride

目的:探讨建立盐酸头孢他美酯质量标准残留溶剂检查方法的标准化过程。方法:以7个企业的盐酸头孢他美酯为例,探讨建立统一残留溶剂检测方法的基本过程。结果:建立了统一的盐酸头孢他美酯残留溶剂检查方法,总结出建立药品质量标准中残留溶剂检查方法的一般规律。结论:提出了建立药品质量标准残留溶剂检查方法的标准化模式。

Objective：To approach the standardization process of establishment of a residual solvent determination method for quality control requirements of cefetamet pivoxil hydrochloride. Method： Cefetamet pivoxil hydrochloride produced by seven manufacturers was chosen as samples, and the general process of establishing a uniform method for determination of residual solvents in the pharmaceuticals for quality control purpose was approached. Results： The uniform method for determination of residual solvents in cefetamet pivoxil hydrochloride was established, and the generic rules for establishment of such kind of method for quality control requirements of pharmaceuticals were summarized. Conclusion：A standardization model of establishing residual solvent determination method for quality control requirements of pharmaceuticals is brought forward.