Purity and reliability are of paramount importance for a treatment given to some of the most vulnerable patients.
USP Filgrastim Reference Standards (RS) help manufacturers address these concerns. Like all of our standards, the Filgrastim RS have been evaluated in a multi-laboratory collaborative study.
Filgrastim System Suitability RS
(1mg per ampule)
For use to support tests included in the Filgrastim monograph:
- Peptide mapping
- Organic impurities, related compounds,
- Impurities with charges different from Filgrastim
- Impurities with molecular weight different from that of Filgrastim
- Limit of high molecular weight proteins
Catalog #1270537
Filgrastim for Bioassay RS
(1μg per ampule)
For assignment of relative potency of Filgrastim using the cell-based bioassay in the USP Filgrastim monograph
- Relative potency aligned with the WHO 2nd IS for Filgrastim
- Each ampule contains 96,815 IU of biological activity in a lyophilized format for added stability
Catalog #1270468
High molecular weight Filgrastim RS
(0.7mg per ampule)
- Contains a defined amount of high molecular weight species of Filgrastim
- Requires less preparation as a peak identification marker
Catalog #1270457