Amphotericin B.
[1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*,19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-β-d-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid;
14,39-Dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid, 33-[(3-amino-3,6-dideoxy-β-d-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-, (1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)- [1397-89-3]
BRIEFING
Amphotericin B. This proposal is based on the version of the monograph official as of May 1, 2020. Based on comments received, the proposal in PF 50(5) has been canceled and is being replaced with a new proposal. The following changes are proposed:
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Update the Chemical Information section.
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Replace the UV test in Identification A with an infrared spectroscopy test.
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Add Identification B based on the retention time agreement with the HPLC procedure in the new Organic Impurities test.
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Add an Organic Impurities test based on a liquid chromatographic procedure validated using the YMC–Pack Pro C18 brand of column with L1 packing. The typical retention time for amphotericin B is about 17 min.
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Delete the Limit of Amphotericin A test.
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Replace the procedure in the Loss on Drying test.
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Add USP Amphotericin B Mixture RS to the USP Reference Standards section to support the new Organic Impurities test.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(BIO4: J. Zhang)
Case ID—SUB-2415
USP REFERENCE STANDARDS FOR PURCHASE
USP Amphotericin B Mixture RSUSP Amphotericin B RS
USP Nystatin RS