来曲唑及来曲唑片药典标准制定研究概述

Establishment of Chinese pharmacopoeia standards for letrozole and Letrozole Tablets

来曲唑及来曲唑片为《中国药典》2020年版二部新增品种。有关物质是药品的关键质量属性,此项药典标准的制定对于药品质量控制起到重要作用。重点针对来曲唑有关物质项的标准起草、复核、公示、审核及确定过程进行详细分析,阐明了来曲唑原料药及片剂药典标准制定的思路和过程,同时也为其他药品标准的提升及药典标准制定提供了参考。

The Monograph of letrozole and letrozole tablets have been added to the 2020 version of Chinese Pharmacopoeia(VolumeⅡ).The impurities control is the key quality attribute of letrozole,so this paper focused on the drafting,review,publicity,review and determination process of letrozole impurities specification.This paper clarified the ideas and processes of pharmacopoeia standard formulation for letrozole and letrozole Tablets,and also provides a reference of the formulation of the pharmacopoeia standard.