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

Impurities/degradation products

Time point

BTS 24631 %w/w

BTS 28777 %w/w

BTS 27732 %w/w

BTS 9636 %w/w

Storage Condition

Initial

ND

ND

0.1

0.4

4 weeks

ND

ND

0.1

0.4

8 weeks

<0.1

<0.1

ND

0.1

0.4

‘Daylight’ cabinet

12 weeks

<0.1

<0.1

ND

0.1

0.4

26 weeks

0.3

0.2

ND

0.1

0.4

ND: Not Detected

Stability data for Flurbiprofen batch TOP006, Stress testing and degradation products

Impurities/degradation products

Time point

BTS 24631 %w/w

BTS 42190 %w/w

Storage Condition

Initial

ND

ND

4 weeks

0.08

ND

Natural north window light

8 weeks

0.09

0.01

12 weeks

0.32

0.02

ND: Not Detected