Overview of USP–NF
The USP–NF is a combination of two compendia: the United States Pharmacopeia (USP) and the National Formulary (NF). It provides standards for a wide range of products including medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The current version, USP–NF 2024, Issue 1, became official on May 1, 2024, and its standards are enforceable by the U.S. Food and Drug Administration (FDA) for medicines manufactured and marketed in the United States.
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This article features the latest release of each monograph and every general chapter for USP 2024. You can download or study the USP 2024 pdf online for free.
Features
- Monographs: Over 4,900 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms.
- General Chapters: More than 330 general chapters providing step-by-step guidance for assays, tests, and procedures.
- Additional Resources: Sections on reagents, indicators, and solutions, plus reference tables.
USP 2024 Monographs
Monographs in the pharmacopeia represent the names, specifications, definitions, and other requirements related to packaging, storage, and labeling. They include procedures, tests, and acceptance criteria to ensure the identity, strength, quality, and purity of the articles. For general requirements related to specific monograph parts, see section 5, "Monograph components." Because monographs may not provide standards for all relevant characteristics, some official substances can comply with USP or NF standards but differ due to their non-standard nature, relevant to their use in specific preparations. Users should ensure the equality of FUND functions or determine these characteristics before use.
Each monograph pdf includes:
- Definition
- Identification
- Assay
- Impurities
- Specific Tests
- Additional Requirements
General Chapters
Each general chapter is assigned a number that appears in angle brackets next to the chapter name (e.g., <chromatography>). General chapters may include:
- Descriptions of tests and procedures for individual monographs.
- Specifications and descriptions of practices and conditions for pharmaceutical compounding.
- General information for interpreting compendial requirements.
- Descriptions of general pharmaceutical storage, dispensing, and packaging practices.
- General guidance for manufacturers of official substances or products.
When referenced in a monograph, the acceptance criteria may be presented after a colon. Some chapters provide an overview of analytical techniques and may refer to other general chapters for detailed procedures and acceptance criteria.
Benefits & Applications
The USP–NF is an essential resource for producing quality prescription, nonprescription, and compounded medicines, excipients, biologics, medical devices, and dietary supplements. It supports quality control, quality assurance, regulatory/compendial affairs, research and development, method development/analytical services, and corporate management. Using USP–NF monographs and methods can help:
- Ensure compliance with U.S. quality standards.
- Adhere 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
The USP–NF is valuable for scientists, professionals, and students working in:
- 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
ALSO READ: British Pharmacopoeia 2024
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Pharmacopoeia
