grade
pharmaceutical primary standard
API family
heparin
form
powder
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecule)
format
neat
General description
Oversulfated Chondroitin Sulfate (OSCS) is a known contaminant in heparin products that led to safety concerns globally. This USP standard is used in identity and impurity testing to detect OSCS contamination using NMR or strong anion exchange chromatography.
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.
Oversulfated Chondroitin Sulfate USP reference standard 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 have 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
Application
Further information is available in the monograph, Heparin Sodium, USP43-NF38 - 2195 of the USP (United States Pharmacopeia).
Other Notes
存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
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