來曲唑及來曲唑片為《中國藥典》2020年版二部新增品種。有關(guān)物質(zhì)是藥品的關(guān)鍵質(zhì)量屬性，此項藥典標準的制定對于藥品質(zhì)量控制起到重要作用。重點針對來曲唑有關(guān)物質(zhì)項的標準起草、復核、公示、審核及確定過程進行詳細分析，闡明了來曲唑原料藥及片劑藥典標準制定的思路和過程，同時也為其他藥品標準的提升及藥典標準制定提供了參考。

The Monograph of letrozole and letrozole tablets have been added to the 2020 version of Chinese Pharmacopoeia (Volume Ⅱ). 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.

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