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USB Pharmacists Pharmacopeia 2007
USP NF 2007
(United States Pharmacopeia/National Formulary)
by US Pharmacopeia)Hardcover - May 2007)
Book Info
(United States Pharmacopeia/National Formulary)
by US Pharmacopeia)Hardcover - May 2007)
Book Info
Published in 2007
ISBN 1889788473
Size 44.00MB
Product Description
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 USPNF
USPNF 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, USPNF 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
USPNF also is an important reference for pharmacies, libraries, universities, and schools of medicine and pharmacy.
How USPNF Helps
Only the USPNF 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 specificationstests, procedures, and acceptance criteriarequired for pharmaceutical manufacturing and quality control.
USPNF 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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