Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-;
9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone [76-25-5]
BRIEFING
Triamcinolone Acetonide. This proposal is based on the version of the monograph official as of May 1, 2020. Based on comments received, the proposal in PF 43(5) has been canceled and is being replaced with a new proposal. It is proposed to revise the monograph with the following changes:
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Revise Identification A to allow the flexibility to use either 197A or 197K.
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Replace the nonspecific UV-based Identification B with a chromatographic retention time agreement as obtained in the proposed Assay.
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Replace the current chromatographic procedure in the Assay which uses an Internal standard solution with a new liquid chromatographic procedure, also proposed for the Organic Impurities test. The HPLC procedure was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for triamcinolone acetonide is about 15 min.
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Replace the existing chromatographic procedure in the Organic Impurities test with a validated liquid chromatographic procedure that is also proposed for the Assay.
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Add the Residue on Ignition test with an acceptance criterion based on FDA-approved specifications.
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Include proposed acceptance criteria for specified, unspecified, and total impurities in the Organic Impurities test based on FDA-approved specifications.
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Replace dimethylformamide with alcohol in the test for Optical Rotation to eliminate the use of hazardous solvents.
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Replace the Loss on Drying test with the Water Determination test due to the hygroscopic nature of the dried material. The calculation base in the Definition is revised from the dried to the anhydrous basis, accordingly.
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Update the storage condition in the Packaging and Storage section per the current USP style.
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Add USP Triamcinolone Acetonide Related Compound B RS and USP Triamcinolone Acetonide Related Compound C RS, and delete USP Fluoxymesterone RS in the USP Reference Standards section to reflect the revised Assay and Organic Impurities test.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM5: R. Ivaturi)
Case ID—SUB-1256, SUB-1316