Merck
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安全信息

A-166

Supelco

Adalimumab (Humira) solution

10.0 mg/mL (12.5 mM Histidine Buffer), certified reference material, Cerilliant®

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CAS号:
331731-18-1

等级

certified reference material

质量水平

300

形式

liquid

特点

Snap-N-Spike®/Snap-N-Shoot®

包装

ampule of 0.25 mL

制造商/商品名称

Cerilliant®

浓度

10.0 mg/mL (12.5 mM Histidine Buffer)

技术

liquid chromatography (LC): suitable

应用

clinical testing

格式

single component solution

储存温度

−20°C

相关类别

一般描述

Adalumimab is a therapeutic monoclonal antibody used for the treatment of psoriasis, rheumatoid arthritis, and Crohn′s disease. Adalimumab (Humira) in solution is a primary certified reference material of the recombinantly expressed and purified therapeutic monoclonal antibody (mAb). The product is traceable to higher order standards from National Institute of Standards and Technology (NIST) through an unbroken chain of comparisons. It satisfies the criterion for certified reference material and primary standard categories according to the ISO requirements. The solution contains not less than 0.25 mL of approximately 10 mg/ml certified solution. The manufacturing process follows the quality control standards, ISO 17034, ISO/IEC 17025, and ISO 9001.

应用

Adalimumab (Humira) solution has been used to determine the metrological traceability for adalimumab (ADL). It is also suitable for in vitro applications such as identification, calibration, and quantification of analytes in analytical and R&D settings.

特点和优势

  • Adalimumab (Humira) content is quantitatively measured by amino acid analysis (AAA).
  • Every raw material employed has been identified and comprehensively characterized using a variety of analytical methods.
  • The fill volume is gravimetrically verified at various stages during the dispensing process using qualified and calibrated balances.
  • Long-term stability has been evaluated under freezer storage conditions (-10 °C to -25 °C).

制备说明

  • Thaw the product in a refrigerator or at room temperature and ensure thorough mixing before use.
  • Avoid refreezing the product once thawed.
  • When spiking into a matrix or diluting to required concentrations, it is recommended to quantitatively transfer the appropriate volume using established laboratory practices.

其他说明

This product′s purpose is for testing. THIS PRODUCT IS NOT INTENDED FOR HUMAN OR THERAPEUTIC USE. For comprehensive details regarding the nature of any hazards and recommended precautions, kindly refer the safety data sheet.

法律信息

CERILLIANT is a registered trademark of Merck KGaA, Darmstadt, Germany
Snap-N-Shoot is a registered trademark of Cerilliant Corporation
Snap-N-Spike is a registered trademark of Merck KGaA, Darmstadt, Germany

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储存分类代码

12 - Non Combustible Liquids

WGK

WGK 2

法规信息

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Quantification of infliximab and adalimumab in human plasma by a liquid chromatography tandem mass spectrometry kit and comparison with two ELISA methods
Tron C, et al.
Bioanalysis, 14(11), 831-844 (2022)

商品

Workflow for Antibody Aggregates and Fragments Analysis

A complete SEC-UV workflow for the characterization of mAb monomers, aggregates, and fragments using Zenix® and Zenix®-C SEC columns, including system suitability testing and forced pH and temperature stress studies.

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