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PHR1662

Amphotericin B

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Amphotericin B

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A propos de cet article

Formule empirique (notation de Hill) :
C47H73NO17
Numéro CAS:
1397-89-3
Poids moléculaire :
924.08
UNSPSC Code:
41116107
EC Number:
215-742-2
NACRES:
NA.24
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

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

SMILES string

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

InChI key

APKFDSVGJQXUKY-ZNVUZQDLSA-N

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 and EP 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.
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.

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pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H372

Hazard Classifications

STOT RE 1

Classe de stockage

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

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificats d'analyse (COA)

Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".

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Consulter la Bibliothèque de documents

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

Numéro d'article de commerce international

RéférenceGTIN
PHR1662-500MG04061835238132