1445550

Monoclonal IgG System Suitability

United States Pharmacopeia (USP) Reference Standard

• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• form: lyophilized (cake)
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C

Description

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets, have been developed and issued under the Authority of the issuing Pharmacopoeia.
For further information and support please go to the website of the issuing Pharmacopoeia.

Application

This USP reference standard is intended for use in specified quality tests and assays as specified in USP compendia.
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

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

This product is part of the USP Biologics program.

Sales restrictions may apply.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable