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Valacyclovir Hydrochloride

Type of Posting: Notice of Intent to Revise

Posting Date: 30–Jun–2011

Targeted Official Date: Interim Revision Announcement, 01–Mar–2012

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 Valacyclovir Hydrochloride monograph. The purpose of the revision is to revise the concentration of palladium standard solutions used in the calibration curve to cover the range of the acceptance criteria for palladium in the Limit of Palladium procedure. In addition, the concentration of valacyclovir related compound E in the Standard solution under Organic Impurities, Procedure 1 is revised to correspond to the acceptance criteria of valacyclovir related compound E.

It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 37(5) [Sep.–Oct. 2011] pursuant to section 7.02 of the Rules and Procedures.

Should you have questions, please contact Leonel Santos, Ph.D, Scientific Liaison to the Expert Committee (301-816-8168 or