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Documentos Principais

PHR1662

Supelco

Amphotericin B

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Amphotericin B

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About This Item

Fórmula empírica (Notação de Hill):
C47H73NO17
Número CAS:
Peso molecular:
924.08
Número CE:
Código UNSPSC:
41116107
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

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

família API

amphotericin b

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 500 mg

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

Formato

neat

temperatura de armazenamento

-10 to -25°C

cadeia de caracteres SMILES

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

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

chave InChI

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

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.

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.

Pictogramas

Health hazard

Palavra indicadora

Danger

Frases de perigo

Declarações de precaução

Classificações de perigo

STOT RE 1

Código de classe de armazenamento

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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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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