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.
Highlights & 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
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