中国药典2025年版指导原则9303“色素检测法建立指导原则”修订概况

    Overview of the Revision to the Guideline 9303 “Guideline for the Establishment of Pigment Detection Methods” in Chinese Pharmacopoeia 2025 Edition

    • 摘要: 中国药典2025年版指导原则9303“色素检测法建立指导原则”,为检测药品中合规使用的色素辅料和可能出现的非法使用色素提供方法指导。本文系统梳理色素分类及命名编号系统,介绍国内外对药用色素的监管情况,解读本次修订的理念与内容,并提出监管和药典编制进一步发展完善的思考与建议。

       

      Abstract: The “Guideline for the Establishment of Pigment Detection Methods” (9303) from the Chinese Pharmacopoeia 2025 edition provides methodological guidance for the detecting both compliant use of pigment as pharmaceutical excipients and potential illegal use. This article comprehensively reviews the classification and nomenclature systems of pigments, introduces domestic and international regulatory frameworks for pharmaceutical pigments, interprets the rationale and specific content of the current revisions, and offers insights and recommendations for further improvements in regulatory oversight and pharmacopoeia compilation.

       

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