Documents
1445550
USP
Monoclonal IgG System Suitability
United States Pharmacopeia (USP) Reference Standard
Recommended Products
grade
pharmaceutical primary standard
form
lyophilized (cake)
manufacturer/tradename
USP
application(s)
pharmaceutical (small molecule)
format
neat
storage temp.
−20°C
1 of 4
This Item | 1213329 | 1304049 | 1570439 |
|---|---|---|---|
| form lyophilized (cake) | form - | form - | form - |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) |
| format neat | format neat | format neat | format neat |
| storage temp. −20°C | storage temp. - | storage temp. - | storage temp. - |
General description
For further information and support please go to the website of the issuing Pharmacopoeia.
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 Code
11 - Combustible Solids
WGK
WGK 2
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
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