USP 33 NF 28 - Further Information

Three-volume combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). USP-NF is an annual publication, comprising of one main publication and two supplements each year.The USP 33-NF 28 becomes official on 1 May 2010.

The First Supplement is available from February 2010 and becomes official on 1 August 2010. The Second Supplement is available from June 2010 and becomes official on 1 December 2010.

The USP-NF provides access to 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, the USP serves as a clear step-by-step guide for the specifications – tests, procedures, and acceptance criteria – required for pharmaceutical manufacturing and quality control.

USP 33 – NF 28 includes more than 4200 monographs for drugs, excipients, biologics and dietary supplements. The monograph design is in a new easy-to-read format with concise language. Format developments include:
Tests and procedures clearly designated in a logical flow
Reorganized content; sub-headings reordered and renamed to meet ICH specifications
Calculations have been expanded to provide more details; added impurity tables and heavy metal units updated to ppm
Preparation of solutions are abbreviated and a new streamlined format used.

The USP-NF is an essential publication for anyone working in pharmaceuticals, biotechnology, dietary supplements, medical devices and gases and veterinary drugs and is also is an important reference for pharmacies, libraries, universities, and schools of medicine and pharmacy.