A-166
阿达木 溶液
10.0 mg/mL (12.5 mM Histidine Buffer), certified reference material, Cerilliant®
产品名称
阿达木 溶液, 10.0 mg/mL (12.5 mM Histidine Buffer), certified reference material, Cerilliant®
grade
certified reference material
form
liquid
feature
Snap-N-Spike®/Snap-N-Shoot®
packaging
ampule of 0.25 mL
manufacturer/tradename
Cerilliant®
concentration
10.0 mg/mL (12.5 mM Histidine Buffer)
technique(s)
liquid chromatography (LC): suitable
application(s)
clinical testing
format
single component solution
storage temp.
−20°C
Quality Level
Legal Information
Snap-N-Spike is a registered trademark of Merck KGaA, Darmstadt, Germany
CERILLIANT is a registered trademark of Merck KGaA, Darmstadt, Germany
Snap-N-Shoot is a registered trademark of Cerilliant Corporation
Application
Adalimumab (Humira) solution has been used to determine the metrological traceability for adalimumab (ADL). It is also suitable for in vitro applications such as identification, calibration, and quantification of analytes in analytical and R&D settings.
Features and Benefits
- Adalimumab (Humira) content is quantitatively measured by amino acid analysis (AAA).
- Every raw material employed has been identified and comprehensively characterized using a variety of analytical methods.
- The fill volume is gravimetrically verified at various stages during the dispensing process using qualified and calibrated balances.
- Long-term stability has been evaluated under freezer storage conditions (-10 °C to -25 °C).
General description
Adalumimab is a therapeutic monoclonal antibody used for the treatment of psoriasis, rheumatoid arthritis, and Crohn′s disease. Adalimumab (Humira) in solution is a primary certified reference material of the recombinantly expressed and purified therapeutic monoclonal antibody (mAb). The product is traceable to higher order standards from National Institute of Standards and Technology (NIST) through an unbroken chain of comparisons. It satisfies the criterion for certified reference material and primary standard categories according to the ISO requirements. The solution contains not less than 0.25 mL of approximately 10 mg/ml certified solution. The manufacturing process follows the quality control standards, ISO 17034, ISO/IEC 17025, and ISO 9001.
Other Notes
This product′s purpose is for testing. THIS PRODUCT IS NOT INTENDED FOR HUMAN OR THERAPEUTIC USE. For comprehensive details regarding the nature of any hazards and recommended precautions, kindly refer the safety data sheet.
Preparation Note
- Thaw the product in a refrigerator or at room temperature and ensure thorough mixing before use.
- Avoid refreezing the product once thawed.
- When spiking into a matrix or diluting to required concentrations, it is recommended to quantitatively transfer the appropriate volume using established laboratory practices.
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
此项目有
Quantification of infliximab and adalimumab in human plasma by a liquid chromatography tandem mass spectrometry kit and comparison with two ELISA methods
Tron C, et al.
Bioanalysis, 14(11), 831-844 (2022)
商品
Characterize mAb monomers, aggregates, and fragments using SEC-UV workflow with Zenix® and Zenix®-C SEC columns.
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