Type of Posting: Notice of Intent to Revise
Posting Date: 28-Feb-2025
Targeted Official Date: 01-Nov-2025; Interim Revision Announcement
Expert Committee: Small Molecules 1
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 1 Expert Committee intends to revise the Valganciclovir for Oral Solution monograph.
Comments with supporting data were received that indicate the concentrations of the Sample stock solution and Sample solution in the Assay cannot be attained by manufacturers. The monograph is being updated to reflect changes to these concentrations. Additionally, the naming of the drug substance peak is being updated from Valganciclovir diastereomer peak 1 and Valganciclovir diastereomer peak 2 to Valganciclovir R-diastereomer and Valganciclovir S-diastereomer, respectively, to reflect the appropriate stereochemistry. It is also proposed to update the current two table format in the test for Organic Impurities, adding a table to the System suitability section to provide relative retention times as information to aid in peak assignment. The Expert Committee proposes to revise the Valganciclovir for Oral Solution monograph with the updates in the Assay, Performance Tests, and the test for Organic Impurities.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 51(3) [May 2025 – Jun. 2025] pursuant to the Rules and Procedures. The comment period for this revision ends on July 31, 2025. In the absence of any adverse comments, the proposed IRA will become official on November 1, 2025.
Should you have any questions, please contact Robyn Fales, Senior Scientist I (rnp@usp.org).