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单词 United States Pharmacopeia
释义

United States Pharmacopeia

中文百科

美国药典

美国药典》(英语:United States Pharmacopeia, USP) 是美国药品( 包括原料药和制剂)的质量控制标准大全。它由美国药典委员会每年更新再版一次。它是美国食品药品监督管理局(FDA)和美国麻醉品管制局的管制行为准则;也是美国和其它几个国家的官方药典。因此,在对其收录的药物及辅料的鉴别、鉴定、检测和纯度测定的方法存在分歧时,美国药典中陈述的方法将具有法律效力。

业内引用《美国药典》时通常简称为USP。实际上在原料名称旁打上USP三个首字母作标记是表明其遵循USP规范,可以药用。

英语百科

United States Pharmacopeia 美国药典

The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopoeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and copyright. The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF." Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise), as well as animal drugs. USP-NF standards also have a role in U.S. federal law; a drug or drug ingredient with a name recognized in USP-NF is deemed adulterated if it does not satisfy compendial standards for strength, quality or purity. USP also sets standards for dietary supplements, and food ingredients (as part of the Food Chemicals Codex). USP has no role in enforcing its standards; enforcement is the responsibility of FDA and other government authorities in the U.S. and elsewhere.

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更新时间:2025/6/17 5:48:41