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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,

分类号:医药、卫生


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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