I-042

Infliximab solution

certified reference material, ampule of 0.25 mL, Cerilliant^®

• CAS Number: 170277-31-3
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material
• Quality Level: 300
• 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

Description

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

Safety Information

• Storage Class Code: 12 - Non Combustible Liquids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable