Pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-, monosodium salt, (6α,11β)-;
11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione 21-(sodium succinate)
Sodium 4-(11β,17-dihydroxy-6α-methyl-3,20-dioxopregna-1,4-dien-21-yl) succinate [2375-03-3]
BRIEFING
Methylprednisolone Sodium Succinate. 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 UNII code for methylprednisolone sodium succinate in the Chemical Information section. Update the IUPAC name.
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Update Identification A per current USP style and clarify the Standard preparation.
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Revise the Assay to remove the cross-reference to Assay for Steroids 〈351〉 and include test details within the Procedure. Add the cross-reference to Ultraviolet-Visible Spectroscopy 〈857〉.
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Update the molecular weight of methylprednisolone hemisuccinate throughout the monograph.
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Update the Sodium Content test per current USP style. Add the cross-reference to Titrimetry 〈541〉. Clarify the reagent tagging of the Titrant.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM5: N. Myers)
Case ID—SUB-161