USP30-NF25 (2007)

The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation. It is published every year [1] by the United States Pharmacopoeial Convention. It forms the basis of enforcement actions by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration and is the official pharmacopoeia of the U.S.A. and many other nations. Therefore, in case of a dispute, those methods for, amongst others, identification, assay and purity determination of a drug substance or excipient which are stated in the USP will be the legally binding ones.

Within the field the compendium is referred to simply as the USP. The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.

Who Needs USP–NF

USP–NF is essential in the following types of industries:

* Pharmaceuticals — prescription and nonprescription drugs
* Biological and biotechnology products
* Blood and blood products
* Cosmetics
* Dietary supplements
* Excipients/other drug ingredients
* Medical devices
* Medical gases
* Veterinary drugs

In each of these industries, USP–NF is an essential resource for scientists, managers, supervisors, and directors in:

* Quality control
* Quality assurance
* Regulatory/compendial affairs
* Research and development
* Method development/analytical services
* Corporate management

USP–NF also is an important reference for pharmacies, libraries, universities, and schools of medicine and pharmacy.
How USP–NF Helps


Only the USP–NF provides the official standards enforceable by the U.S. Food and Drug Administration for drugs and related products manufactured and marketed in the United States. In addition, it serves as a clear, step-by-step guide for the specifications—tests, procedures, and acceptance criteria—required for pharmaceutical manufacturing and quality control.


USP–NF helps to:

* Ensure compliance with official standards
* Work to world-recognized standards of precision and accuracy
* Validate test results against proven benchmarks
* Establish and validate in-house standard operating procedures, procedures, and specifications
* Expedite new product development and approvals


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