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
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