S. No.
Name of impurities
Photolytic degradation (%) (1.2Million lux hours & 200 WH/m2)
Temperature/ Humidity degradation (%) (60°C ± 2 and 80%RH ± 5% for 48 hours)
Thermal degradation (%) (105°C±2 for 24 hours )
1
DAB Impurity-A
ND
ND
ND
2
DAB-2B
ND
0.04
0.21
3
DAB Impurity-C
0.09
0.08
0.10
4
DAB Impurity-H
ND
ND
ND
5
DAB Impurity-D
0.02
ND
ND
6
DAB Impurity-E
ND
0.09
0.11
7
DAB Impurity-K
0.01
0.01
ND
8
DAB Impurity-J
0.02
1.32
0.02
9
DAB Impurity-G
0.06
0.04
0.71
10
Total unknown impurities
0.39
0.12
0.10
11
Total impurities
0.59
1.71
1.24
12
% of Degradation
0.29
1.41
0.94
Table 3.1:
Result of Force Degradation study in Dabigatran etexilate mesylate