來(lái)曲唑及來(lái)曲唑片為《中國(guó)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(xiàng)藥典標(biāo)準(zhǔn)的制定對(duì)于藥品質(zhì)量控制起到重要作用。重點(diǎn)針對(duì)來(lái)曲唑有關(guān)物質(zhì)項(xiàng)的標(biāo)準(zhǔn)起草、復(fù)核、公示、審核及確定過(guò)程進(jìn)行詳細(xì)分析，闡明了來(lái)曲唑原料藥及片劑藥典標(biāo)準(zhǔn)制定的思路和過(guò)程，同時(shí)也為其他藥品標(biāo)準(zhǔn)的提升及藥典標(biāo)準(zhǔn)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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