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Stability data for Flurbiprofen batch TOP003

Further identified impurities (Ph Eur impurities B, C, D and E)

2-(4-biphenylyl) propionic acid (Ph Eur impurity A)

Storage Condition

Appearance and Colour

LOD at 105°C

Any other impurity

Total impurities

Time point

Content

Maximum 0.1 % each

White to Cream Powder

Not more than 0.1 %

99.0 to 101.0 % in dry substance

Maximum 0.2 % each

Maximum 1.0 %

Limits

Maximum 0.5 %

Initial

White Powder

<0.01

100.0

0.28

0.07

ND

0.36

3 months 6 months 3 months 6 months

White Powder White Powder White Powder White Powder

<0.01 0.02 <0.01 0.01 <0.01 0.02

100.2 100.3 99.8 100.0

0.28 0.27 0.28 0.27 0.28 0.28

0.06 0.08 0.07 0.07 0.07 0.08

ND ND ND ND

0.35 0.36 0.36 0.34 0.36 0.35

25°C/60%RH

30°C/60%RH

3 months 6 months

White Powder White Powder

100.5 100.2

ND ND

40°C/75%RH

ND: Not Detected LOD: Loss on Drying