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Informazioni su questo articolo
grade
pharmaceutical primary standard
agency
USP
API family
dextran
form
crystalline
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecule)
pharmaceutical
format
neat
General description
Dextran 1 is a low molecular weight dextran fraction used in hypersensitivity testing prior to dextran administration. It acts by binding circulating antibodies to reduce anaphylactic risk. The USP reference standard is used in identity and content uniformity testing.
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.
Analysis Note
Other Notes
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Classe di stoccaggio
11 - Combustible Solids
Punto di infiammabilità (°F)
Not applicable
Punto di infiammabilità (°C)
Not applicable
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