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Merck
CN

1179708

USP

Dextran 40

Dextran 40 United States Pharmacopeia (USP) Reference Standard

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24
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grade

pharmaceutical primary standard

API family

dextran

form

crystalline

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

General description

Dextran 40 is a low molecular weight branched polysaccharide composed of α-1,6-linked glucose units. It is used clinically as a plasma volume expander and pharmaceutically as a carrier or stabilizer. The USP standard supports identity testing and molecular weight distribution analysis.

The USP biologics carbohydrates category includes a variety of carbohydrate-based substances that are essential in the development and manufacturing of therapeutic products. These carbohydrates play crucial roles in biological processes and are often utilized as excipients, stabilizers, or active ingredients in pharmaceuticals. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of carbohydrate 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.

Application

Dextran 40 USP reference standard for use in specified quality tests and assays.

Also used to prepare a system suitability solution during optical and specific rotation of Dextran 40 by liquid chromatography method coupled to a Refractive index detector.

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.  ​

Other Notes

Sales restrictions may apply.
This product is part of the USP Biologics program.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Dextran 40
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 47(5), 1309-1309 (2022)

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