4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamideBenzenesulfonamide,4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl];
p-[5-p-Tolyl-3-(trifluoromethyl)-pyrazol-1-yl]benzenesulfonamide 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide [169590-42-5]
BRIEFING
Celecoxib. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to revise the monograph with the following changes:
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Add the chemical structure, and update the molecular weight and chemical names of celecoxib in the chemical information section.
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In the Assay, add a Note for pre-column heating of the Mobile phase to meet the resolution requirement.
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In the Assay, replace "about" with "NLT" in the Run time to provide flexibility.
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Add a Note for the relative retention times in the System suitability section in the Assay.
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Add Sensitivity solution and revise the Signal-to-noise ratio requirement in the Organic Impurities test to strengthen the monograph.
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Add the Relative standard deviation requirement based on the Standard solution in the Organic Impurities test to strengthen the monograph.
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In the Assay and Organic Impurities test, revise the Resolution requirement for both of the critical pairs, compound A and Celecoxib, as well as Celecoxib and related compound B, from NLT 1.8 to 1.5, on the basis of comments received.
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Add a table and Note in the System suitability section within the test for Organic Impurities to present Relative retention times as an aid in peak assignment. Revise the table in the Acceptance criteria section to list only 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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In the test for Organic Impurities, the Note of "Disregard any impurity peak less than 0.05%" in the Acceptance criteria section is replaced with "The reporting threshold is 0.05%", to align with International Council for Harmonisation (ICH) terminology.
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Delete the redundant chemical information of USP Celecoxib RS from the USP Reference Standards section.
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Update the molecular weights of USP Celecoxib Related Compound A RS and USP Celecoxib Related Compound B RS in the USP Reference Standards section to be consistent with the current IUPAC values.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM2: S. Parepalli, W. Yang)
Correspondence Number—C315977
USP REFERENCE STANDARDS FOR PURCHASE
USP Celecoxib RSUSP Celecoxib Related Compound A RS
USP Celecoxib Related Compound B RS