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美國藥典

USP

美國藥典The United States Pharmacopeia (USP) www.usp.org
《美國藥典》(USP, United States Pharmacopeia) 是美國藥品( 包括原料藥和制劑)的質(zhì)量控制標準大全。它由美國藥典委員會每年更新再版一次[1]。它是美國食品藥品監(jiān)督管理局(FDA)和美國麻醉品管制局的管制行為準則;也是美國和其它幾個國家的官方藥典。因此, 在對其收錄的藥物及輔料的鑒別、鑒定、檢測和純度測定的方法存在分歧時,美國藥典中陳述的方法將具有法律效力。


業(yè)內(nèi)引用美國藥典時通常簡稱為USP. 實際上在原料名稱旁打上USP三個首字母作標記是表明其遵循USP規(guī)范,可以藥用。
美國藥典是美國政府對藥品質(zhì)量標準和檢定方法作出的技術(shù)規(guī)定,也是藥品生產(chǎn)、使用、管理、檢驗的法律依據(jù)。NF收載了美國藥典(USP)尚未收入的新藥和新制劑。

USP 中國
美藥典醫(yī)藥標準物質(zhì)研發(fā)(上海)有限公司
中國上海
張江高新區(qū)李冰路 67 弄
11 號樓
郵編 201203
電話: +86-21-51370600
傳真: +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