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Principaux documents

1478210

USP

Oligosaccharide System Suitability Mixture A

United States Pharmacopeia (USP) Reference Standard

Synonyme(s) :

IgG N-glycans

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About This Item

Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

pharmaceutical primary standard

Famille d'API

oligosaccharide sst mixture

Forme

solid

Fabricant/nom de marque

USP

Application(s)

pharmaceutical (small molecule)

Format

mixture

Catégories apparentées

Description générale

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.

Remarque sur l'analyse

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.  ​

Autres remarques

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.
Sales restrictions may apply.

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable

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Certificats d'analyse (COA)

Lot/Batch Number

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