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. It is proposed to revise the monograph with the following changes:
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Update the molecular weight in 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 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.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(BIO4: J. Zhang)
Case ID—SUB-1104
USP REFERENCE STANDARDS FOR PURCHASE
USP Amphotericin B Mixture RSUSP Amphotericin B RS
USP Nystatin RS