Chromatographic method for size base impurity analysis of Filgrastim
Instrument Type: HPLC (Biocompatible)
The Thermo Scientific Dionex ultimate 3000 Bio LC system is Applied for the Aggregate impurities analysis of Filgrastim. The analysis was performed on Mabpac SEC-1 using the IP monograph method. IP has revised the resolution criteira from 2.0 to 3.0. The critical resolution of Aggregate and monomer was more than 3.0 .