I-042
Infliximab solution
certified reference material, ampule of 0.25 mL, Cerilliant®
About This Item
Prodotti consigliati
Grado
certified reference material
Livello qualitativo
Stato
liquid
Caratteristiche
Snap-N-Spike®/Snap-N-Shoot®
Confezionamento
ampule of 0.25 mL
Produttore/marchio commerciale
Cerilliant®
tecniche
liquid chromatography (LC): suitable
applicazioni
clinical testing
Formato
single component solution
Temperatura di conservazione
−20°C
Descrizione generale
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.
Applicazioni
Caratteristiche e vantaggi
- 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.
Nota sulla preparazione
- 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.
Altre note
Note legali
Prodotti correlati
Codice della classe di stoccaggio
12 - Non Combustible Liquids
Classe di pericolosità dell'acqua (WGK)
WGK 2
Punto d’infiammabilità (°F)
Not applicable
Punto d’infiammabilità (°C)
Not applicable
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Articoli
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.
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