Introduction
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This page provides access to the latest editions of all USP 2025 monographs and general chapters (United States Pharmacopeia 48 – NF 43).
United States Pharmacopeia 48 – NF 43
The United States Pharmacopeia (USP) and the National Formulary (NF) are two authoritative references that have been merged into one publication, forming the USP 2025 PDF (United States Pharmacopeia 48 – NF 43).
This combined edition offers comprehensive standards and guidance for pharmaceuticals, biological products, chemical substances, dosage forms, excipients, medical devices, dietary supplements, and other healthcare preparations.
For medicinal products manufactured and distributed within the United States, the Food and Drug Administration (FDA) recognizes and may enforce the most current USPNF standards as official.
You can conveniently view, study, or download the USP 2025 PDF (United States Pharmacopeia 48 – NF 43) for free.
General Chapters
Each General Chapter is identified by a numerical code placed within angle brackets next to the chapter title (e.g., Chromatography). These chapters cover:
Descriptions of analytical tests and methods applicable to individual monographs
Specifications and best practices for pharmaceutical compounding
General information on interpreting compendial standards
Guidelines for proper storage, dispensing, and packaging of pharmaceuticals
Overall recommendations for manufacturers of official substances and finished products
When referenced in a monograph, the acceptance criteria for a general chapter are typically listed following the main content.
Some chapters serve as introductory overviews for analytical techniques and may refer to additional chapters containing detailed methods, procedures, or acceptance standards.
Monographs - USP 2025
Monographs in the pharmacopeia represent official documentation of a drug’s name, description, definition, labeling, storage, and packaging requirements.
They also detail the procedures, tests, and quality standards necessary to confirm a product’s integrity and compliance.
Refer to Section 5, Monograph Components, for comprehensive guidance on general monograph specifications.
Because some substances may meet USP or NF criteria while differing in certain aspects, users should confirm equivalency or verify the relevant parameters before application to ensure consistency across preparations.
Within the pharmacopeia, monographs provide the official names, definitions, specifications, and regulatory information concerning labeling, packaging, and storage.
Each monograph defines tests, analytical methods, and acceptance criteria that ensure the identity, potency, quality, and purity of pharmaceutical substances.
Section 5, titled Monograph Components, outlines general requirements for each part of a monograph.
Since not every monograph addresses all possible attributes, some recognized substances may comply with USP or NF standards but still differ in properties due to their specific or non-standard characteristics.
In such cases, users should verify the functional equivalence or evaluate key properties before use to ensure consistent performance or interchangeability.
This document includes a PDF version of every drug monograph in the following structure:
Each Monograph PDF Contains:
- Definition
- Identification
- Assay
- Impurities
- Specific Tests
- Additional Requirements
