I-042
Infliximab (Remicade) solution
certified reference material, ampule of 0.25 mL, Cerilliant®
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
General description
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
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
Legal Information
related product
Storage Class Code
12 - Non Combustible Liquids
WGK
WGK 2
Regulatory Information
Certificates of Analysis (COA)
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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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