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Merck
CN

1032007

USP

两性霉素 B

United States Pharmacopeia (USP) Reference Standard

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关于此项目

经验公式(希尔记法):
C47H73NO17
化学文摘社编号:
分子量:
924.08
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24
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产品名称

两性霉素 B, United States Pharmacopeia (USP) Reference Standard

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

grade

pharmaceutical primary standard

API family

amphotericin b

form

solid

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

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Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Application

This USP reference standard is intended for use in specified quality tests and assays.
Also used to prepare standard and system suitability solutions as described in the following United States Pharmacopeia (USP) monographs:
  • Amphotericin B
  • Amphotericin B for Injection

General description

Amphotericin B is a polyene antifungal agent that binds to ergosterol, disrupting fungal cell membrane integrity. It is used for systemic fungal infections. The USP reference standard is essential for potency determination and impurity analysis in amphotericin B drug products.

The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

Other Notes

Sales restrictions may apply.
This product is part of the USP Biologics program.
This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets, has been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

pictograms

Health hazard

signalword

Danger

hcodes

Hazard Classifications

STOT RE 1

存储类别

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

法规信息

涉药品监管产品
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历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Amphotericin B for Injection
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 315-315 (2018)
Amphotericin B
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 314-314 (2020)

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