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 StandardsPosted by Tim Sandle
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