I-042
Infliximab (Remicade) solution
certified reference material, ampule of 0.25 mL, Cerilliant®
About This Item
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
WGK
WGK 2
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Regulatory Information
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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Articles
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