等级
pharmaceutical primary standard
形式
lyophilized (cake)
制造商/商品名称
USP
应用
pharmaceutical (small molecule)
格式
neat
储存温度
−20°C
一般描述
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.
For further information and support please go to the website of the issuing Pharmacopoeia.
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:
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
This product is part of the USP Biologics program.
Sales restrictions may apply.
WGK
WGK 2
闪点(°F)
Not applicable
闪点(°C)
Not applicable
法规信息
常规特殊物品
Analytical procedures for recombinant therapeutic monoclonal antibodies
United States Pharmacopeia/National Formulary, 39(3), 6565-6565 (2016)
相关内容
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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