1445550
USP
Monoclonal IgG System Suitability
United States Pharmacopeia (USP) Reference Standard
About This Item
Recommended Products
grade
pharmaceutical primary standard
form
lyophilized (cake)
lyophilized powder
manufacturer/tradename
USP
application(s)
pharmaceutical (small molecule)
format
neat
storage temp.
−20°C
General description
This reference standard is used to evaluate the performance of analytical methods for monoclonal antibodies.
The USP biologics monoclonal antibodies (mAb) category includes a range of therapeutic proteins that are designed to target specific antigens, providing effective treatments for various diseases, including cancers and autoimmune disorders. Monoclonal antibodies are produced using hybridoma technology and are essential in both diagnostics and therapeutics. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of monoclonal antibody products throughout their lifecycle.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
Application
It is also used to prepare system suitability solution for the mobile phase as per the chapter 129 “Analytical procedures for recombinant therapeutic monoclonal antibodies” of United States Pharmacopeia (USP) for the measurement of:
- Low-molecular-weight species (LMWS, fragments) of monoclonal antibodies (mAbs) by size exclusion-high performance liquid chromatography (SE-HPLC)
- Product-related impurities such as non-glycosylated molecules, half antibodies, and fragments by capillary sodium dodecyl sulfate (CE-SDS) electrophoresis
Analysis Note
Other Notes
Storage Class
11 - Combustible Solids
wgk_germany
WGK 2
flash_point_f
Not applicable
flash_point_c
Not applicable
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