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Table 4 Stability of formulated BK0023 maintained at 5 and 25°C. Aliquots of samples were assayed at time 0, 1 and 2 months by RP-HPLC and SE-HPLC

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

Assay

Storage time

Temperature 5°C

Temperature 25°C

  

BK0023 mg/ml

Main peak%

Sum of impurities%

BK0023 mg/ml

Main peak%

Sum of impurities%

RP-HPLC

0

0.29

99.6

0.4

0.29

99.6

0.4

1 month

0.29

99.6

0.4

0.28

99.6

0.3

3 months

0.28

99.6

0.4

0.28

99.1

0.9

SE-HPLC

0

0.28

99.6

0.4

0.29

99.6

0.4

1 month

0.27

99.6

0.4

0.28

99.6

0.3

3 months

0.28

99.6

0.4

0.28

99.1

0.9

  1. Aliquots of samples were assayed at time 0, 1 and 2 months by RP-HPLC and SE-HPLC. Peak purity and total impurities (or aggregates in the case of SE-HPLC analysis) are reported as percentage of total peak areas.
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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