Amoxicillin and Clavulanate Potassium for Oral Suspension

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 aww@usp.org).