Thursday, 6 July 2017

PHARMACOPEIAL FORUM VOL. 43 No.2


News from the USP Pharmacopeial Forum:

Chapter 1231 “Water for Pharmaceutical Purposes” (Revision proposal target, USP41-NF36 1st Supplement)

Proposed revisions are as follows:
  • Add information to the section on Sampling for microbial and chemical considerations intended to provide more clarification and guidance on sample hold times.
  • Include some modifications to terminology in the Microbial Evaluations section.
  • Provide clarification under Chemical Evaluations regarding compliance with elemental impurities requirements.

Posted by Dr. Tim Sandle