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Stability data for Flurbiprofen batch TOP001, Stress testing and degradation products

Impurities/degradation products

Time point

Storage Condition

BTS 40312 %w/w

BTS 9636 %w/w

Initial

<0.1

0.2

1 week 2 weeks 1 week 2 weeks 1 week 2 weeks

ND ND

0.2 0.2 0.2 0.2 0.2 0.2

70°C, in air, in the presence of water

<0.1 <0.1 <0.1 ND

70°C, in air, in the presence of 1M sodium hydroxide

70°C, in air, in the presence of 1M hydrochloric acid

ND: Not Detected (limit of detection 0.05 %)