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Stability data for Flurbiprofen batch TOP002

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

99.8

0.29

0.05

ND

0.35

3 months 6 months 3 months 6 months 3 months 6 months

White Powder White Powder White Powder White Powder White Powder White Powder

0.01 0.01 0.01 0.01

100.0 99.9 100.2 100.1 100.2 100.0

0.29 0.28 0.29 0.32 0.29 0.31

0.06 0.09 0.07 0.09 0.07 0.08

ND ND ND ND ND ND

0.36 0.38 0.37 0.42 0.37 0.39

25°C/60%RH

30°C/60%RH

<0.01 0.01

40°C/75%RH

ND: Not Detected LOD: Loss on Drying