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USP–NF

USP–NF

The USP–NF is a combination of two 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. The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about the USP–NF and how it is developed.

A new edition with 2016 standards—USP 40–NF 35—becomes official May 1, 2017

An official Spanish edition is available in print.

What's Inside USP 40–NF 35

  • Annotated ListLearn what monographs, general chapters, reagents, and tables are affected by changes.

Subscriber Resources

Features

  • More than 4,900 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP–NF monograph.
  • More than 300 general chapters providing clear, step-by-step guidance for assays, tests, and procedures
  • Focus-specific charts and a combined index help you find the information you need
  • Helpful sections on reagents, indicators, and solutions, plus reference tables
  • Includes new General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

Available Formats

PRINT

Includes a four-volume print main edition and two separate print supplements. Printed on thick, durable paper stock, for laboratory and manufacturing use. Each volume contains a complete table of contents and index. Shipped with a slipcase for easy access and storage.

ONLINE

Provides access to all updates posted online during the 12 months after subscription start date. Online features include viewable chemical structures for more than 700 impurities; FAQs; quick search, bookmarking, printing, and copy/paste functions; My USP–NF—a special online tool that lets you save searches and bookmark pages—plus printable PDFs, pronunciations, and 3-D chemical structures. Available for one year for one or more users. (View online technical support.)

USB FLASH DRIVE

The USB flash drive format provides the same quality content found in print, along with viewable chemical structures for more than 700 impurities; FAQs; and quick search, bookmarking, printing, and copy/paste functions. Each main edition and supplement integrates content from all previous editions. Subscribers will receive updates that occur during their subscription period on a new cumulative USB flash drive.

Flash Drive Technical Requirements

  • Operating System: Windows® 7 (64 bit) – Desktop environment (Server environment is not supported)
  • System Requirements:
    • 256 MB RAM or more
    • 350 MB free disk space
  • Web Browsers:
    • Microsoft© Internet Explorer 8.0, 9.0, and 10.0
    • Google© Chrome

Benefits & Applications

The 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/compendial affairs, research and development, method development/analytical services, and corporate management. USP–NF monographs and methods can help to

  • Ensure compliance with required U.S. quality 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 medicine and pharmacy
  • Veterinary drugs