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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:

grade

certified reference material

Quality Level

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

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vibrant-m

A-166

Adalimumab (Humira) solution

vibrant-m

S-144

Silybum Mix solution

format

single component solution

format

multi-component solution

format

-

format

-

form

liquid

form

-

form

liquid

form

-

feature

Snap-N-Spike®/Snap-N-Shoot®

feature

Snap-N-Spike®/Snap-N-Shoot®

feature

-

feature

-

packaging

ampule of 0.25 mL

packaging

ampule of 1 mL

packaging

-

packaging

vial of 100 μg

manufacturer/tradename

Cerilliant®

manufacturer/tradename

Cerilliant®

manufacturer/tradename

-

manufacturer/tradename

-

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

Storage Class

12 - Non Combustible Liquids

wgk_germany

WGK 2


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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)

Articles

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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