USP 42 - NF 37 The United States Pharmacopeia and National Formulary 2019

The United States Pharmacopeia and National Formulary (USP–NF) contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The current version deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States.
USP standards are used in more than 140 countries around the world.
• More than 4,900 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms.
• More than 350 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
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
An ISO certified Spanish translation (certified to ISO 17100:2015) of USP-NF compendial content is available in print as the Spanish edition.