Type of Posting: Notice of Intent to Revise
Posting Date: 01–Aug–2012
Targeted Official Date: Standard Revision Process, 01–Dec–2013
Expert Committee: Monographs—Excipients
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 USP Monographs—Excipients Expert Committee intends to revise the Color of Solution test in the Methylpyrrolidone monograph. The purpose of the revision is to:
- Replace water with a Comparison solution equivalent to B9 listed in the European Pharmacopeia to reflect the range of color from colorless to slightly yellow representative of the pharmaceutical grade excipients available on the market.
- Change the Acceptance criteria from “The Sample has the color of water” to “The Sample is not more intensely colored than the Comparison solution.”
It is anticipated that the revision will be published as an In-Process Revision for public comment in PF 38(5) [Sep. – Oct. 2012] pursuant to section 7.02 of the Rules and Procedures.
Should you have questions, please contact Galina Holloway, Scientific Liaison to the Expert Committee (301-816-8133 or firstname.lastname@example.org).