BRIEFING
Acyclovir Ointment. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:
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Add Identification B, which is based on the UV spectra agreement as obtained in the Assay. Accordingly, revise the Detector in the Assay to support the proposed Identification B.
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In the test for Assay:
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Delete System suitability solution B, as it is not needed to establish System suitability criteria. Accordingly, System suitability solution A is renamed as System suitability solution.
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Replace guanine as a reagent with USP Guanine RS in the System suitability solution.
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Rephrase the Sample solution to provide flexibility.
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Add the particle size for the HPLC column in the Chromatographic system.
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Add the Tailing factor in the Suitability requirements section.
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Revise the System suitability requirement for the Relative standard deviation to be consistent with the expectations of a modern chromatographic system.
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Add a new Organic Impurities test based on an HPLC procedure validated with the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for acyclovir is about 8.7 min.
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In the test for Limit of Guanine:
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Replace guanine as a reagent with USP Guanine RS in the System suitability solution.
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Add the Sensitivity solution to support the addition of the Signal-to-noise ratio requirement
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Add System suitability requirements for Relative standard deviation and Signal-to-noise ratio.
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Delete the reference to Microbial Enumeration Test 〈61〉 under Specific Tests, as the existing Acceptance criteria is not related to this chapter. Add a new test for Microbial Enumeration Tests 〈61〉 based on the approved specifications.
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Update the USP Reference Standards section to include USP Guanine RS to support the Assay and Limit of Guanine test.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM1: S. Parepalli)
Case ID—SUB-999