Amphotericin B Impurity Standards

Amphotericin B impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Amphotericin B-related impurities during analytical method development, method validation, and regulatory filing. As a polyene antifungal, Amphotericin B requires precise characterisation of its process impurities, degradation products, and related substances to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) monograph requirements. Allmpus Laboratories manufactures and supplies a comprehensive library of Amphotericin B impurity standards, each provided with a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). All products are held in-stock for rapid dispatch and are suitable for use in ANDA and DMF regulatory submissions.

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3-DEAMINO-3-HYDROXYAMPHOTERICIN B

Chemical Name: (1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,...

CAS No:
1228440-88-7

Molecular Formula: C47H72O18

Molecular Weight: 925.1

CAT No:
ALL-A09495

Keywords: OC([C@H]([C@H](C1)O)[C@@](C[C@H](/C=C/C=...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

AMPHOTERICIN B

Chemical Name: Abelcet; Abelecet; AmBisome; Ampho-Moron...

CAS No:
1397-89-3

Molecular Formula: C47H73NO17

Molecular Weight: 924.1

CAT No:
ALL-A09493

Keywords: OC(C1)[C@@H](C(O)=O)[C@@](C[C@H](/C=C/C=...

Inventory Status:DELIVERY IMMEDIATE

COA MSDS

AMPHOTERICIN B EP IMPURITY A

Chemical Name: Amphotericin A (28, 29-Dihydro-Amphoteri...

CAS No:
1405-32-9

Molecular Formula: C47H75NO17

Molecular Weight: 926.1

CAT No:
ALL-A09494

Keywords: O[C@@H](C1)[C@@H](C(O)=O)[C@H](C[C@H](/C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

AMPHOTERICIN B EP IMPURITY B

Chemical Name: Amphotericin X1 (as per EP)

CAS No:
136135-57-4

Molecular Formula: C48H75NO17

Molecular Weight: 938.1

CAT No:
ALL-A09496

Keywords: O=C1C[C@]([H])(O)C[C@]([H])(O)CC[C@@]([H...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

AMPHOTERICIN B EP IMPURITY C

Chemical Name: Amphotericin X2 (as per EP)

CAS No:
136135-61-0

Molecular Formula: C49H77NO17

Molecular Weight: 952.1

CAT No:
ALL-A09497

Keywords: O=C1C[C@]([H])(O)C[C@]([H])(O)CC[C@@]([H...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

AMPHOTERICIN B ETHYL ESTER

Chemical Name: Ethyl (1R,3S,5R,6R,9R,11R,15S,16R,17R,18...

CAS No:
55298-62-9

Molecular Formula: C49H77NO17

Molecular Weight: 952.1

CAT No:
ALL-A09498

Keywords: O=C([C@H]1[C@@](C[C@H](/C=C/C=C/C=C/C=C/...

Inventory Status:DELIVERY IMMEDIATE

COA MSDS

AMPHOTERICIN B IMPURITY 1

Chemical Name: (1R,3S,6R,9R,11R,15S,16R,17R,18S,19E,21E...

CAS No:
N.A.

Molecular Formula: C47H73NO16

Molecular Weight: 908.1

CAT No:
ALL-A09499

Keywords: C[C@H]1O[C@@H](O[C@@H]2C[C@@H]3O[C@@](O)...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

Key Impurity Variants Available

Amphotericin B EP Impurity A — CAS 1405-32-9, a fermentation-related substance used in EP assay specificity testing
Amphotericin B EP Impurity B — CAS 136135-57-4, a structurally related macrolide substance included in the EP related-substances test
Amphotericin B EP Impurity C — a co-produced related substance characterized for use in EP impurity profiling
Amphotericin B Aglycon Impurity — CAS 106799-07-9, formed by loss of the mycosamine sugar from the parent macrolide
Amphotericin B EP Reference Standard — CAS 1397-89-3, the primary pharmacopeial standard used alongside impurity markers for system suitability

Allmpus Capability for This Drug Family

Amphotericin B and its related substances present a distinct synthetic and analytical challenge because of the molecule's size, the conjugated heptaene chromophore, and its poor stability in solution and under light exposure. Allmpus Laboratories' analytical chemistry and synthetic chemistry teams work within R&D and manufacturing facilities accredited by USFDA, EU GMP, EDQM, KFDA, and COFEPRIS, supporting isolation, purification, and structural characterization of macrolide-class impurities of this kind. Each standard is intended to be supplied with supporting analytical data-HPLC purity, NMR, and mass spectral confirmation-for direct use in method development, degradation studies, and regulatory documentation. Where a required impurity is not part of the current catalogue, our teams can undertake custom isolation or synthesis on request, including scale-up to gram quantities for extended stability programs.

Frequently Asked Questions

What analytical data is supplied with Allmpus Amphotericin B impurity standards?

Standards are intended to be supplied with a Certificate of Analysis and supporting structural data, typically including HPLC purity and spectroscopic confirmation, for use in method validation and regulatory submissions.

Can Allmpus isolate or synthesize an Amphotericin B-related substance not currently listed?

Yes. Our synthetic and analytical chemistry groups undertake custom isolation and synthesis of macrolide-class impurities, including aglycone and fermentation-related variants, on a case-by-case basis.

Are these standards approved for use in Amphotericin B drug products?

Allmpus impurity standards are supplied strictly for laboratory, research, and analytical use-including method development and stability-indicating assay validation-and are not intended for human consumption or clinical administration.