Monday, 28 July 2014

USP37-NF32 – items of interest

The USP–NF is a single–volume combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances and preparations are featured in the USP. Excipient monographs are in the NF.

Here are some items of interest from the new edition:

General Chapters

645:     Water Conductivity

Revision to the following sections: Introduction, Instrument Specifications and Operating Parameters, and Bulk Water

1197:   Good Distribution Practices for Bulk Pharmaceutical Excipients

Section 1: Introduction and Scope; Section 2: Quality, Organization, and Documentation; Section 4: Returned Goods, Dispatch, Transport, Importation, Adulteration, and Traceability; Section 5: Excipients Used in Pharmacy Compounding; and Appendix: Definitions and Acronyms


1191    Rheometry [a new chapter]

Monographs

Heparin Sodium, changes to the monograph are:

IDENTIFICATION
1H NMR spectrum, Test A; Chromatographic Identity, Test B; Anti-Factor Xa to Anti-Factor IIa Ratio, Test C; Molecular Weight Determinations, Test D (added); and Identification Tests—General, Sodium, Test E

ASSAY
Anti-Factor IIa Potency

IMPURITIES
Limit of Galactosamine in Total Hexosamine, Nucleotidic Impurities, and Protein Impurities

ADDITIONAL REQUIREMENTS
USP Reference Standards

Posted by Tim Sandle