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美国药典

USP

美国药典The United States Pharmacopeia (USP) www.usp.org
《美国药典》(USP, United States Pharmacopeia) 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[1]。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。
美国药典是美国政府对药品质量标准和检定方法作出的技术规定,也是药品生产、使用、管理、检验的法律依据。NF收载了美国药典(USP)尚未收入的新药和新制剂。

USP 中国
美药典医药标准物质研发(上海)有限公司
中国上海
张江高新区李冰路 67 弄
11 号楼
邮编 201203
电话: +86-21-51370600
传真: +86-21-51370610

The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Our Impact 
Our Vision for the Future 
Our History 
Our Commitment to Quality 
Our Mission
To improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
Our People
USP is a nonprofit public health organization whose work is accomplished by a body of more than 1,000 volunteer experts who work under USP's strict conflict–of–interest rules to set its scientific standards. USP's contributions to public health are enriched by the participation and oversight of these volunteers who represent pharmacy, medicine, and other healthcare professions as well as academia, government, the pharmaceutical and food industries, health plans, and consumer organizations. USP's volunteers and standards–setting processes are supported by more than 500 USP staff members, who work at USP's five locations: Rockville, MD, USA (Headquarters); Basel, Switzerland; Hyderabad, India; Shanghai, China; and São Paulo, Brazil.
Our Programs and Services
USP's activities have a significant impact on promoting quality and protecting the public health worldwide. Click on the links below to learn more.
Product Quality–Documentary Standards 
Medicines and Dietary Supplements 
Food Ingredients 
Product Quality–Reference Standards 
Product Quality–Verification Services 
Education and Events 
Healthcare Quality and Safety 
Promoting Drug Quality in Developing Countries