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USP
USP USP

美國(guó)藥典The United States Pharmacopeia (USP)
《美國(guó)藥典》(USP, United States Pharmacopeia) 是美國(guó)藥品( 包括原料藥和制劑)的質(zhì)量控制標(biāo)準(zhǔn)大全。它由美國(guó)藥典委員會(huì)每年更新再版一次[1]。它是美國(guó)食品藥品監(jiān)督管理局(FDA)和美國(guó)麻醉品管制局的管制行為準(zhǔn)則;也是美國(guó)和其它幾個(gè)國(guó)家的官方藥典。因此, 在對(duì)其收錄的藥物及輔料的鑒別、鑒定、檢測(cè)和純度測(cè)定的方法存在分歧時(shí),美國(guó)藥典中陳述的方法將具有法律效力。

業(yè)內(nèi)引用美國(guó)藥典時(shí)通常簡(jiǎn)稱(chēng)為USP. 實(shí)際上在原料名稱(chēng)旁打上USP三個(gè)首字母作標(biāo)記是表明其遵循USP規(guī)范,可以藥用。
美國(guó)藥典是美國(guó)政府對(duì)藥品質(zhì)量標(biāo)準(zhǔn)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(yàn)的法律依據(jù)。NF收載了美國(guó)藥典(USP)尚未收入的新藥和新制劑。


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 S?o 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
 

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