Type of Posting: Notice of Intent to Revise
Posting Date: 29–Aug–2014
Targeted Official Date: TBD
Expert Committee: Medicines Compendium—South Asia
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Medicines Compendium—South Asia Expert Committee intends to revise General Chapter <12> Drug Product Performance. The purpose of the revision is to update the General Chapter to correlate it with a Commentary that was published in the July 2014 AAPS Journal. The current General Chapter <12> Drug Product Performance is posted here.
Please note the following specific changes to be made:
- The term “optimally bioavailable” will be changed throughout the general chapter to “optimum product performance.”
- The dissolution conditions for Case 3 drugs, where Q=85% in 30 minutes, will be changed to Q=85% in 15 minutes.
Should you have any questions, please contact Erika Stippler, Ph.D., Director, Dosage Form Performance Laboratory, (301-816-8323, ess@usp.org).