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A-166

Supelco

Adalimumab (Humira) solution

10.0 mg/mL (12.5 mM Histidine Buffer), certified reference material, Cerilliant®

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CAS Number:
331731-18-1
UNSPSC Code:
41116107
NACRES:
NA.21

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®

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

Related Categories

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.

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).

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.

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.

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

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WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

常规特殊物品

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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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)

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