Merck
CN
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文件

安全信息

I-042

Supelco

Infliximab (Remicade) solution

certified reference material, ampule of 0.25 mL, Cerilliant®

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CAS号:
170277-31-3

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®

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

Infliximab, a purified chimeric IgG monoclonal antibody protein, is created from recombinant DNA technology. It has both mouse and human components to effectively block the activity of tumor necrosis factor-alpha (TNF-α). Infliximab is used to stimulate the immune system of our body and treat certain diseases, including ulcerative colitis, active rheumatoid arthritis, and ankylosing spondylitis.

This product is a certified reference material, consisting of a pure substance within an aqueous solvent solution, 12.5 mM histidine buffer. This standard is prepared and certified under the ISO 17034, ISO/IEC 17025, and ISO 9001 standards, meeting the requirements of a certified reference material and a primary standard per ISO guidelines. This primary standard is suitable to prepare calibrators and/or controls.

应用

Infliximab (Remicade) solution is suitable for analytical and R&D applications for in vitro identification, calibration, and quantification.

特点和优势

  • Infliximab (Remicade) content is measured via quantitative amino acid analysis (AAA).
  • Ready to use solution.
  • Shelf life and retest date is determined by long term stability studies.
  • The standard is created with precise gravimetric preparation techniques, using fully qualified and calibrated balances that adhere to ISO 17025 standards.
  • The density and material certification are traceable to the SI and higher-order reference materials through mass measurement, calibration, and instrument qualification.
  • The AAA, high-performance liquid chromatography (HPLC) ultraviolet (UV)/mass spectrometry (MS) calibration certified techniques establish traceability.
  • Traceability is ensured to higher order standards from NIST through an unbroken chain of comparisons.

制备说明

  • Thaw contents at either room or refrigerated temperature and mix well prior to usage.
  • Do not refreeze the product after thawing it.
  • Established good laboratory practices should be used when quantitatively transferring the appropriate volume for spiking into a matrix or for dilution purposes.

其他说明

This product′s purpose is for testing. THIS PRODUCT IS NOT INTENDED FOR HUMAN OR THERAPEUTIC USE. Please refer to the safety data sheet for specific information regarding any hazards and appropriate precautions to be taken.

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

常规特殊物品

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索取COA

Infliximab
StatPearls [Internet] (2023)

商品

Charge Variant Analysis (CVA) with Strong Cation Exchange

Learn about the separation of several charge variants of two monoclonal antibodies, NISTmAb and Infliximab, using a polymeric cation exchange column and MS-compatible mobile phases.

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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