Technical Information:
01 Washed with water for injection(WFI) according to EP and USP 02 Bacterial endotoxins less than 0.25EU/ml based on EP 2.6.14 and USP<85> 03 Eto residual less than 1ug/ml according to the EMEA CPMP/QWP 159. 04 Sterilization facility certified according to ISO 11135 05 Particle count less than 5 (>25um), less than 50(>10um)