1133580

Oversulfated Chondroitin Sulfate

United States Pharmacopeia (USP) Reference Standard

• NACRES: NA.24
• UNSPSC Code: 41116107

Proprietà

• grade: pharmaceutical primary standard
• agency: USP
• API family: heparin
• form: powder
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: neat

Descrizione

General description

Oversulfated Chondroitin Sulfate (OSCS) is a prominent contaminant found in heparin that is connected to adverse clinical events. OSCS exhibits plasma anticoagulant activity and the capability to activate prekallikrein to kallikrein.

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

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.

Application

Oversulfated Chondroitin Sulfate USP reference standard suitable for use in specified USP compendial tests and assays. Also used to prepare system suitability solutions for the identification of heparin sodium by proton NMR (Nuclear magnetic resonance) spectroscopy and chromatography method.

Further information is available in the monograph, Heparin Sodium, USP43-NF38 - 2195 of the USP (United States Pharmacopeia).

Other Notes

Oversulfated Chondroitin Sulfate (OSCS) is a prominent contaminant found in heparin that is connected to adverse clinical events. OSCS exhibits plasma anticoagulant acti

Oversulfated Chondroitin Sulfate (OSCS) is a prominent contaminant found in heparin that is connected to adverse clinical events. OSCS exhibits plasma anticoagulant activity and the capability to activate prekallikrein to kallikrein. 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

Sales restrictions may apply.

This product is part of the USP Biologics program.

Informazioni sulla sicurezza

• Classe di stoccaggio: 11 - Combustible Solids
• wgk: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable