The recommended storage condition after dilution is influenced by the quality of the solvent used. While specific storage conditions may vary, it is generally advised to store the diluted product at 2-8 °C. The stability of the diluted solution will also depend on the solvent's quality, which can affect how long the product can be kept after dilution.
A-166
Adalimumab solution
10.0 mg/mL (12.5 mM Histidine Buffer), certified reference material, Cerilliant®
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certified reference material
Quality Segment
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
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
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
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Cet article | |||
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| grade certified reference material | grade certified reference material | grade - | grade - |
| format single component solution | format multi-component solution | format - | format - |
| application(s) clinical testing | application(s) - | application(s) clinical testing | application(s) - |
| technique(s) liquid chromatography (LC): suitable | technique(s) - | technique(s) - | technique(s) - |
| packaging ampule of 0.25 mL | packaging ampule of 1 mL | packaging - | packaging vial of 100 μg |
| form liquid | form - | form liquid | form - |
Classe de stockage
12 - Non Combustible Liquids
wgk
WGK 2
flash_point_f
Not applicable
flash_point_c
Not applicable
Certificats d'analyse (COA)
Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".
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What is the recommended storage condition after diluting the product? How long can it be kept after dilution?
1 answer-
Helpful?
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What is the extinction coefficient of this CRM?
1 answer-
The extinction coefficient is not determined or reported for this product. Concentration is measured by determining total protein content through quantitative amino acid analysis. Data is provided in the Certificate of Analysis for HPLC-UV-MS analysis, but direct spectrophotometric analysis is not performed.
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What is the approximate concentration of adalimumab (humira) in A-166?
1 answer-
The target concentration of this standard is 10 mg/mL. The actual concentration is reported on the lot-specific Certificate of Analysis. See the link below for a sample COA:
https://www.cerilliant.com/shopOnline/COA.aspx?itemno=ceebedfd-7433-411d-8f61-5e06225f4e1d&lotno=FN04112201Helpful?
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