BRIEFING
Valganciclovir for Oral Solution. This proposal is based on the version of the monograph official as of May 1, 2024. On the basis of comments received, a revision to the Assay is necessary to update the concentration and preparation of the Standard solution, Sample stock solution, and Sample solution. In addition, the following revisions are proposed:
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In the test for Organic Impurities:
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Update the Standard solution to reflect a concentration equivalent to the unspecified degradation product limit.
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Add a table and Note to the System suitability section to present relative retention times as an aid in peak assignment.
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Relocate the relative retention time information for fumaric acid, a possible formulation component, to the table in the System suitability section and append (if present) to the name.
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Add relative retention times for other related compounds based on available information.
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Revise the table in the Acceptance criteria to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.
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In the Acceptance criteria, replace the numerical reporting threshold with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility. For more information about this change, please see the USP Compendial Notice “New Chapter 〈477〉 User-Determined Reporting Thresholds and its Implementation in USP–NF Monographs”.
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The references to Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉 are separated to more clearly communicate the requirements associated with each of the general chapters.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
The comment period for this revision ends on July 31, 2025. In the absence of any significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of November 1, 2025.
(SM1: R. Fales)
Case ID—SUB-1194