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PHR1662

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Amphotericin B

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Amphotericin B
Empirical Formula (Hill Notation):
C47H73NO17
CAS Number:
1397-89-3
Molecular Weight:
924.08
EC Number:
215-742-2
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0000005
traceable to Ph. Eur. Y0001361
traceable to USP 1032007
traceable to USP

API family

amphotericin b

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

InChI

1S/C47H73NO17/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/h5-18,27-38,40-44,46,49-54,56-58,61H,19-26,48H2,1-4H3,(H,59,60)/b6-5-,9-7-,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

InChI key

APKFDSVGJQXUKY-ZNVUZQDLSA-N

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General description

Amphotericin B is a macrolide antibiotic used to treat systemic fungal infections.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Amphotericin B may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography technique.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC1692 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H372

Precautionary Statements

P260 - P264 - P270 - P314 - P501

Hazard Classifications

STOT RE 1

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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High-performance liquid chromatographic determination of amphotericin B in a liposomal pharmaceutical product and validation of the assay
Eldem T and Arican-Cellat N
Journal of Chromatographic Science, 38(8), 338-344 (2000)
Small Animal Clinical Pharmacology (2008)
Desiree Van Haute et al.
International journal of pharmaceutics, 569, 118603-118603 (2019-08-12)
Conventional quantitation of drug content in the liposome formulation involves the breakdown of bulk liposomes, which ignores details on the distribution of the active pharmaceutical ingredient (API) and excipients in liposomes of different sizes. The objective of this study is

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