1405-32-9Amphotericin B EP Impurity A

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Catalogue No.:	VE0011358
CAS No.:	1405-32-9
Mol. Formula:	C47H75NO17
Mol. Weight:	926.1 g/mol

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Additional information on CAS 1405-32-9

Parent drug

Amphotericin B

IUPAC Name

Amphotericin A (28, 29-Dihydro-Amphotericin B)

Pharmacopoeial Synonyms

28,29-Dihydro-Amphotericin B

Other Synonyms

N/A

Smiles

C[C@H]1/C=C/C=C/CC/C=C/C=C/C=C/C=C/[C@@H](C[C@H]2[C@@H]([C@H](C[C@](O2)(C[C@H](C[C@H]([C@@H](CC[C@H](C[C@H](CC(=O)O[C@H]([C@@H]([C@@H]1O)C)C)O)O)O)O)O)O)O)C(=O)O)O[C@H]3[C@H]([C@H]([C@@H]([C@H](O3)C)O)N)O

InChI

InChI=1S/C47H75NO17/c1-27-17-15-13-11-9-7-5-6-8-10-12-14-16-18-34(64-46-44(58)41(48)43(57)30(4)63-46)24-38-40(45(59)60)37(54)26-47(61,65-38)25-33(51)22-36(53)35(52)20-19-31(49)21-32(50)23-39(55)62-29(3)28(2)42(27)56/h5-6,8,10-18,27-38,40-44,46,49-54,56-58,61H,7,9,19-26,48H2,1-4H3,(H,59,60)/b6-5+,10-8+,13-11+,14-12+,17-15+,18-16+/t27-,28-,29-,30+,31+,32+,33-,34-,35+,36+,37-,38-,40+,41-,42+,43+,44-,46-,47+/m0/s1

Description

Amphotericin B EP Impurity A (CAS 1405-32-9) is a defined process-related and/or degradation-associated impurity of the polyene macrolide amphotericin B, structurally retained within the polyhydroxylated macrolactone framework. With molecular formula C47H75NO17 and molecular weight 926.1 g/mol, it requires orthogonal characterization because closely related polyene isomers and oxidized analogues can exhibit near-coincident chromatographic behavior. Assignment and quantification typically rely on reversed-phase LC coupled to diode-array detection and high-resolution LC-MS or LC-MS/MS, with NMR used for structural confirmation when isolated. Regulatory evaluation centers on impurity profiling, mass balance, and specification setting for pharmacopeial compliance.