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PHR1662

Supelco

Amphotericin B

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):
Amphotericin B
Empirical Formula (Hill Notation):
C47H73NO17
Número CAS:
Peso molecular:
924.08
Número EC:
NACRES:
NA.24

Nível de qualidade

300

grau

certified reference material
pharmaceutical secondary standard

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

formato

neat

rastreabilidade da farmacopeia

USP
traceable to PhEur Y0000005
traceable to PhEur Y0001361
traceable to USP 1032007

temperatura de armazenamento

-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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Descrição geral

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.

Aplicação

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.
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.

Nota de análise

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

Outras notas

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.

Nota de rodapé

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.

Código de classe de armazenamento

13 - Non Combustible Solids

WGK

WGK 3

Ponto de fulgor (ºF)

Not applicable

Ponto de fulgor (ºC)

Not applicable

Certificado de análise

Certificado de origem

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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