Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)-;
Cortisol 21-(sodium succinate) [125-04-2]
BRIEFING
Hydrocortisone 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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Update the molecular weight of hydrocortisone sodium succinate in the Chemical Information section and in the Assay.
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Update the molecular weight of hydrocortisone hemisuccinate in the Assay.
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Update Identification A as 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 monograph procedure. Add the reference to Ultraviolet-Visible Spectroscopy 〈857〉.
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Delete the Sodium Content test from the Specific Tests section and add it to the Other Components section and update it per current USP style. Add the cross-reference to Titrimetry 〈541〉. Clarify the reagent tagging of the Titrant.
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Add the Other Components section to accommodate change #5.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM5: N. Myers)
Case ID—SUB-172