Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 22–Nov–2013
Official Date: 01–Dec–2014
Expert Committee: Monographs—Excipients
A revision to the harmonized Stage 6 standard for Alcohol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Rev. 2 Cover Sheet. This revision to the Alcohol monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.
Changes from the proposed revision 2 stage 6 USP–NF monograph originally posted on September 27, 2013 include:
- The acceptance criterion for the Ultraviolet Absorption test was revised from “Curve: The absorption curve is smooth” to “Curve: The spectrum shows a steadily rising curve with no observable peaks or shoulders.”
- For the “Clarity of Solution” test, “Reference suspension A” is changed to “Standard suspension A” to be consistent with the USP style guide.
These changes will be incorporated into and become official in the Second Supplement to USP 37–NF 32. This revised harmonization Stage 6 standard for Alcohol supersedes the Stage 6 standard posted on September 27, 2013.
Should you have any questions about the Alcohol monograph, please contact Kevin Moore (301-816-8369 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Emily Meyer (301-230-7438 or email@example.com).