1478210

Oligosaccharide System Suitability Mixture A

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): IgG N-glycans
• NACRES: NA.24
• UNSPSC Code: 41116107

Properties

• grade: pharmaceutical primary standard
• agency: USP
• API family: oligosaccharide sst mixture
• form: solid
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: mixture

Description

General description

Oligosaccharide System Suitability Mixture A is composed of structurally distinct carbohydrate fragments used in glycan analysis. It is employed to assess chromatographic resolution, system performance, and method suitability for oligosaccharide profiling.

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

Oligosaccharide System Suitability Mixture A USP reference standard suitable for use in specified USP compendial tests and assays.

Also used to prepare AB and APTS-labeled standard solutions for liquid chromatographic and capillary electrophoresis separation labeling.

Additionally, used to separate simple biantennary N-linked oligosaccharide chains with no or low levels of sialylated structures.

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.

This product 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.

Safety Information

• Storage Class: 11 - Combustible Solids
• flash_point_f: Not applicable
• flash_point_c: Not applicable