Type of Posting: Notice of Intent to Revise
Posting Date: 23–Nov–2011
Targeted Official Date: Revision Bulletin, Date to Be Determined
Expert Committee: Monographs–Small Molecules 1
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-Small Molecules 1 Expert Committee intends to revise the specifications for the Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> in the Amoxicillin and Clavulanate Potassium for Oral Suspension monograph to reflect the FDA-approved limits.
The following changes are proposed:
- Raise the limit of the total aerobic microbial count from 102 cfu/g to 103 cfu/g.
- Raise the limit of the total combined molds and yeasts count from 5 x 101 cfu/g to 102 cfu/g.
It is anticipated that the proposed revision will be published as a Revision Bulletin at a date yet to be determined, pursuant to section 7.02 of the Rules and Procedures.
Should you have questions, please contact Ahalya Wise, Scientific Liaison to the Expert Committee (301-816-8161 or firstname.lastname@example.org).