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I-042

Supelco

Infliximab (Remicade) solution

certified reference material, ampule of 0.25 mL, Cerilliant®

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CAS Number:

grade

certified reference material

Quality Level

form

liquid

feature

Snap-N-Spike®/Snap-N-Shoot®

packaging

ampule of 0.25 mL

manufacturer/tradename

Cerilliant®

technique(s)

liquid chromatography (LC): suitable

application(s)

clinical testing

format

single component solution

storage temp.

−20°C

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vibrant-m

Y0002110

Infliximab BRP

vibrant-m

Y0002047

Infliximab

Supelco

Supelco

S-144

Silybum Mix solution

format

single component solution

format

neat

format

neat

format

multi-component solution

form

liquid

form

-

form

-

form

-

feature

Snap-N-Spike®/Snap-N-Shoot®

feature

-

feature

-

feature

Snap-N-Spike®/Snap-N-Shoot®

packaging

ampule of 0.25 mL

packaging

-

packaging

-

packaging

ampule of 1 mL

manufacturer/tradename

Cerilliant®

manufacturer/tradename

EDQM

manufacturer/tradename

EDQM

manufacturer/tradename

Cerilliant®

General description

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.

Application

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

Features and Benefits

  • 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.

Preparation Note

  • 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.

Other Notes

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.

Legal Information

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

Storage Class Code

12 - Non Combustible Liquids

WGK

WGK 2


Certificates of Analysis (COA)

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Infliximab
StatPearls [Internet] (2023)

Articles

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.

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.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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