制藥用水廣泛用于藥品生產(chǎn)過程和藥物制劑的制備，同時也被用作溶劑、沖洗劑等。制藥用水的質(zhì)量直接影響藥品的質(zhì)量，與藥品的安全息息相關(guān)。概述分析了中國、美國和歐盟制藥用水的管理、質(zhì)量控制要求及其差異，同時探討了制藥用水分類、注射用水制法及制藥用水微生物控制，為國內(nèi)制藥用水相關(guān)技術(shù)標(biāo)準(zhǔn)建設(shè)及科學(xué)監(jiān)管提供參考。

Water for pharmaceutical use is widely uesd in the processing and manufacture of pharmaceutical products, but also used as solvent, washing agent, etc. Based on the impact of water for pharmaceutical use on drug safety, this issue discuss the differences between different countries about the quality control of water for pharmaceutical use and the classification of medicinal water, preparation of water for injection and microbial control of pharmaceutical water, which provide reference to establish technical standards and satisfied the current quality control for scientific supervision.

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