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Informacje o tej pozycji
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
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
Other Notes
Klasa składowania
11 - Combustible Solids
flash_point_f
Not applicable
flash_point_c
Not applicable
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