书名:The United States pharmacopeia
责任者:United States Pharmacopeial Convention.
ISBN\ISSN:9781936424221,1936424223 0195-7996
出版时间:2014
出版社:United States Pharmacopeial Convention,
摘要
USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP-NF monograph (100KB). Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures Focus-specific charts and a combined index helps you find the information you need Benefits & Applications USP-NF offers convenient, comprehensive information for all phases of producing quality prescription, nonprescription and compounded medicines; excipients; biologics; medical devices; and dietary supplements. It is essential for quality control, quality assurance, regulatory/compendia affairs, research and development, method development/analytical services, and corporate management. Using USP-NF monographs and methods can help to Ensure compliance with official U.S. standards Work to world-recognized standards of precision and accuracy Validate test results against proven benchmarks Establish and validate in-house standard operating procedures, and specifications Expedite new product development and approvals A Valuable Reference for Scientists, professionals, and students working in or with Pharmaceuticals-prescription and nonprescription drugs Biological and biotechnology products Blood and blood products Compounded preparations Cosmetics Dietary supplements Excipients/other drug ingredients Medical devices Medical gases Medical libraries Pharmacies Schools of medicines and pharmacy Veterinary drugs
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目录
Mission and Preface
Mission and Preface, USP 37-NF 32 and Supplements 6265
People
Officers (2010-2015) 6273
Board of Trustees (2010-2015) 6273
Council of Experts (2010-2015) 6273
Expert Committees (2010-2015) 6274
Expert Panels (2010-2015) 6274
Advisory Groups (2010-2015) 6281
Admissions
New Articles Appearing in This Supplement 6283
Annotated List: Monographs, General Chapters, Reagents, and Tables Affected by Changes Appearing in This Supplement 6284
Notices
General Notices and Requirements 6293
General Chapters
General Tests and Assays 6319
Biological Tests and Assays 6331
Other Tests and Assays 6337
Physical Tests and Determinations 6346
General Information 6395
Dietary Supplements 6439
Reagents, Indicators, and Solutions
Reagents, Indicators, and Solutions 6449
Reagent Specifications 6454
Chromatographic Columns 6454
Reference Tables
Containers for Dispensing Capsules and Tablets 6455
Description and Relative Solubility of USP and NF Articles 6465
Dietary Supplements
Official Monographs 6525
C1Excipients
USP and NF Excipients, Listed by Category 6549
Monographs, NF 32
Official Monographs for NF 32 6599
Monographs, USP 37
Official Monographs for USP 37 6573
Index l-1
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