Saturday, 22 November 2014

USP 2014, 2nd supplement

With: United States Pharmacopiea and National Formulary, 2nd Supplement to USP37-NF32. Official 01 Dec 2014, there are some items of interest:

a)      General Chapters

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

Physical Tests and Determinations

Chapter 791 pH

Chapter 1196 Pharmacopeial Harmonization

Chapter 1229.6 Liquid Phase Sterilization

Chapter 1240  Virus Testing of Human Plasma for Further Manufacture [NEW]

b)      USP and NF Excipients

Updates to the following

  • Polysorbate 80: Identification – Test A and Infrared Absorption, Test B (added), Assay – Composition of Fatty Acids, Impurities – Heavy Metals, Method II, Specific Tests – Specific Gravity and Viscosity – Capillary Viscometer Methods or Rotational Rheometer Methods, Additional Requirements - USP Reference Standards.
  • Cupric Sulfate: Specific Tests – Loss on Drying, Additional Requirements – Labelling (added)

Posted by Tim Sandle