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Merck
CN

1179708

USP

右旋糖酐40

Dextran 40 United States Pharmacopeia (USP) Reference Standard

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UNSPSC代码:
41116107
NACRES:
NA.24
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等级

pharmaceutical primary standard

API类

dextran

表单

crystalline

制造商/商品名称

USP

应用

USP Biologics
pharmaceutical (small molecule)

包装形式

neat

一般描述

Dextran 40 is a low molecular weight branched polysaccharide composed of α-1,6-linked glucose units. It is used clinically as a plasma volume expander and pharmaceutically as a carrier or stabilizer. The USP standard supports identity testing and molecular weight distribution analysis.

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

右旋糖酐 40 USP参考标准品用于指定质量测试和分析。

还可用于制备系统适用性溶液,用于通过液相色谱和折光率检测器测定右旋糖酐 40的旋光度和比旋光度。

分析说明

这些产品仅供测试和化验使用。它们不适用于人类或动物,也不能用于诊断、治疗或治愈任何类型的疾病。

其他说明

可能适用相应的销售限制。
该产品是美国药典生物制品计划的一部分。

储存分类代码

11 - Combustible Solids

WGK

WGK 2

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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Dextran 40
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 47(5), 1309-1309 (2022)

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