Saturday, 28 February 2015

New USP #38


Official 01 May 2015

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

Listed are items in which changes have been made to existing official text.

General Tests and Assays:

General Requirements for Tests and Assays

Chapter 1       Injections

Chapter 7       Labelling [NEW]

Apparatus for Tests and Assays

Chapter 41      Balances

Chemical Tests and Assays

Chapter 231    Heavy Metals [deleted]

Chapter 251    Lead

Physical Tests and Determinations

Chapter 659    Packaging and Storage Requirements - Introduction (deleted), Packing, General Definitions, Injection Packaging (added), and Storage Conditions

Chapter 660    Containers - Glass

Description, Specific Tests, and Functionality

Chapter 697 Container Content for Injections [NEW]

Chapter 852    Atomic Absorption Spectroscopy [NEW]

Chapter 853    Fluorescence Spectroscopy [NEW]

Chapter 854    Mid-Infrared Spectroscopy [NEW]

Chapter 857    Ultraviolet-Visible Spectroscopy [NEW]

Chapter 911    Viscosity-Capillary Viscometer Methods

Chapter 787    Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections [NEW]

Chapter 1852  Atomic Absorption Spectroscopy – Theory and Practice [NEW]

Chapter 1853  Fluorescence Spectroscopy - Theory and Practice [NEW]

Chapter 1854  Mid-Infrared Spectroscopy - Theory and Practice [NEW]

Chapter 1857  Ultraviolet-Visible Spectroscopy - Theory and Practice [NEW]

Posted by Tim Sandle