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Table 2 Product related impurities of purified bulk BK0023 preparations

From: Preclinical and clinical phase I studies of a new recombinant Filgrastim (BK0023) in comparison with Neupogen®

Impurity

Method

Result

BK0023 oxydized forms

RP-HPLC

< 1%

BK0023 aggregate forms

SE-HPLC

< 1%