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Merck
CN

1478210

USP

Oligosaccharide System Suitability Mixture A

United States Pharmacopeia (USP) Reference Standard

别名:

IgG N-glycans

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UNSPSC代码:
41116107
NACRES:
NA.24
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等级

pharmaceutical primary standard

API类

oligosaccharide sst mixture

表单

solid

制造商/商品名称

USP

应用

USP Biologics
pharmaceutical (small molecule)

包装形式

mixture

一般描述

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.

应用

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.

分析说明

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.  ​

其他说明

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.

储存分类代码

11 - Combustible Solids

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable


历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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{?212? Oligosaccharide analysis}
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 41(5), 6623-6623 (2017)

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