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Merck
CN

1445550

USP

Monoclonal IgG System Suitability

United States Pharmacopeia (USP) Reference Standard

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关于此项目

UNSPSC代码:
41116107
NACRES:
NA.24

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等级

pharmaceutical primary standard

表单

lyophilized (cake)
lyophilized powder

制造商/商品名称

USP

应用

USP Biologics
pharmaceutical (small molecule)

包装形式

neat

储存温度

−20°C

相关类别

一般描述

This reference standard is used to evaluate the performance of analytical methods for monoclonal antibodies.

The USP biologics monoclonal antibodies (mAb) category includes a range of therapeutic proteins that are designed to target specific antigens, providing effective treatments for various diseases, including cancers and autoimmune disorders. Monoclonal antibodies are produced using hybridoma technology and are essential in both diagnostics and therapeutics. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of monoclonal antibody products 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

This USP reference standard is intended for use in specified quality tests and assays as specified in USP compendia.
It is also used to prepare system suitability solution for the mobile phase as per the chapter 129 “Analytical procedures for recombinant therapeutic monoclonal antibodies” of United States Pharmacopeia (USP) for the measurement of:

  • Low-molecular-weight species (LMWS, fragments) of monoclonal antibodies (mAbs) by size exclusion-high performance liquid chromatography (SE-HPLC)
  • Product-related impurities such as non-glycosylated molecules, half antibodies, and fragments by capillary sodium dodecyl sulfate (CE-SDS) electrophoresis

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 MSDS 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 2

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

常规特殊物品

历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Analytical procedures for recombinant therapeutic monoclonal antibodies
United States Pharmacopeia/National Formulary, 39(3), 6565-6565 (2016)

相关内容

Intact Mass Analysis of Monoclonal Antibodies

Discover our wide variety of products for intact mass analysis of monoclonal antibodies, including size-exclusion columns (SEC), ion exchange columns, reverse-phase columns, HPLC buffers, MALDI matrices and standards, high-purity solvents, reagents, tools for protein sample preparation, and certified reference materials.

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