A-166

Adalimumab solution

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

• Numéro CAS: 331731-18-1
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.21

Propriétés

• Qualité: certified reference material
• Niveau de qualité: 300
• Forme: liquid
• Caractéristiques: Snap-N-Spike^®/Snap-N-Shoot^®
• Conditionnement: ampule of 0.25 mL
• Fabricant/nom de marque: 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
• Température de stockage: −20°C

Description

Description générale

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.

Caractéristiques et avantages

• 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).

Notes préparatoires

• 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.

Autres remarques

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.

Informations légales

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

Informations sur la sécurité

• Code de la classe de stockage: 12 - Non Combustible Liquids
• Classe de danger pour l'eau (WGK): WGK 2
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable