Phosphonic acid, (3-methyloxiranyl)-, (2R-cis)-, compd. with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1);
(1R,2S)-(1,2-Epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) [78964-85-9]
BRIEFING
Fosfomycin Tromethamine. This proposal is based on the version of the monograph official as of May 1, 2020. The primary scope of this revision is to correct the equation in the calculation in the Organic Impurities procedure. The following changes to the monograph are also proposed:
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In the Assay, specify the concentration of the System suitability solution to provide clarity and flexibility.
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Add the "NLT" requirement to the Run time in the Assay and the Organic Impurities test.
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Delete the Note and Impurity Table 1 from the Assay and add both to the System suitability section of the Organic Impurities test as per current USP style, and rename the table as Table 1. Revise the Note and the table (Table 1).
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Consequently, add a table (Table 2) to the Acceptance criteria section of Organic Impurities test to list the limits for specified impurities, any unspecified impurity, and total impurities. For more information about this format change, please see the USP Compendial Notice “Organic Impurities Procedures: Format Change for Presenting Relative Retention Times″.
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Remove the term Note from the System suitability requirements section of the Assay as per current USP style.
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In the test for Organic Impurities:
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Based on available data, add the Relative standard deviation requirement in the Suitability requirements section.
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Update the chemical name of tromethamine based on the updated chemical information.
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In the Acceptance criteria section, revise "Any other individual impurity" to "Any unspecified impurity" to be consistent with ICH Q3A terminology.
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Replace the description of "Disregard any peak less than" with "The reporting threshold" to be consistent with current USP style.
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Additionally, minor editorial changes have been made to update the monograph to current USP style.
The comment period for this revision ends on Sep 30, 2023. 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 January 1, 2024.
(SM1: T. Devarshi)
Correspondence Number—C319691