BRIEFING
Methylprednisolone Acetate Injectable Suspension. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments received, a correction is made to the equation in the Assay to address the variation of the internal standard concentration between the Standard solution and Sample solution. The following changes to the monograph are also proposed:
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Update the Relative standard deviation requirement in the Assay for clarity.
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Replace the prednisone reagent with an equivalent reference standard, USP Prednisone RS, in the Assay.
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Add storage condition requirement to the Packaging and Storage section for clarity.
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Add USP Prednisone RS to the USP Reference Standards section to support the proposed revision in the Assay.
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, 2024. In the absence of any significant adverse comment, it is proposed to implement this revision via an Interim Revision Announcement with an official date of November 1, 2024.
(SM5: P. Jagu)
Correspondence Number—C327982, SUB-285