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
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.
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
存储类别
12 - Non Combustible Liquids
wgk
WGK 2
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
常规特殊物品
低风险生物材料
此项目有
商品
Characterize mAb monomers, aggregates, and fragments using SEC-UV workflow with Zenix® and Zenix®-C SEC columns.
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.
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| I-042-0.25ML | 04061842637027 |