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

VOLUME 1

Mission Statement and Preface vii

People 2010-2015 Revision Cycle xv

      Officers xv

      Board of Trustees xv

      Council of Experts xv

      Expert Committees xvi

      Advisory Groups xxiii

      In Memoriam xxiii

Members of the United States Pharmacopeial Convention, as of May 31, 2013 xxv

2012 Recognition of Monograph and Reference Material Donors xxxi

Articles of Incorporation xxxiii

USP Governance xxxiv

      Bylaws xxxiv

      Rules and Procedures xxxiv

      USP Policies xxxiv

Admissions xxxvii

      Articles Admitted to USP 37 by Supplement xxxvii

      New Articles Appearing in USP 37 That Were Not Included in USP 36 Including Supplements xxxviii

      Articles Included in USP 36 But Not Included in USP 37 xxxix

      Annotated List xl

Notices

      General Notices and Requirements 1

General Chapters

      See page 29 for detailed contents

      General Tests and Assays 33

      General Requirements for Tests and Assays 33

      Apparatus for Tests and Assays 49

      Microbiological Tests 52

      Biological Tests and Assays 77

      Chemical Tests and Assays 140

      Physical Tests and Determinations 273

      General Information 511

      Dietary Supplements 1319

Reagents, Indicators, and Solutions 1367

      Reagent Specifications 1372

      Indicators and Indicator Test Papers 1441

      Solutions 1443

      Buffer Solutions 1443

      Colorimetric Solutions 1445

      Test Solutions 1445

      Volumetric Solutions 1453

      Chromatographic Columns 1462

Reference Tables

      Containers for Dispensing Capsules and Tablets 1467

      Description and Relative Solubility of USP and NF Articles 1477

      Approximate Solubilities of USP and NF Articles 1536

      Atomic Weights 1544

      Alcoholometric Table 1549

      Intrinsic Viscosity Table 1551

      Thermometric Equivalents 1553

Index

      Combined Index to USP 37 and NF 32 I-1

VOLUME 2

Guide to General Chapters vii

Notices

      General Notices and Requirements xi

USP 37

Monographs

      Official Monographs for USP 37, A-l 1555

Index

      Combined Index to USP 37 and NF 32 I-1

VOLUME 3

Guide to General Chapters vii

Notices

      General Notices and Requirements xi

USP 37

Monographs

      Official Monographs for USP 37, J-Z 3461

Index

      Combined Index to USP 37 and NF 32 I-1

VOLUME 4

Guide to General Chapters vii

Notices

      General Notices and Requirements xi

Dietary Supplements

      Official Monographs 5231

NF 32

Admissions

      Articles Admitted to NF 32 by Supplement 5819

      New Articles Appearing in NF 32 That Were Not Included in NF 31 Including Supplements 5819

      New Articles Appearing in NF 32 5819

      Annotated List 5820

Excipients

      USP and NF Excipients, Listed by Category 5821

Monographs

      Official Monographs for NF 32 5831

      Combined Index to USP 37 and NF 32 I-1

中国医科院医学信息研究所