S. No.
Name of impurity
Conditions for degradation
Control sample (%)
Acid degradation (1N HCl / at RT / 1Hour)
Base degradation (1N NaOH / at RT/ 2 hours)
Oxidative degradation (3%v/v H
2
O
2
/ at RT / 12 Hours )
1
DAB Impurity-A
ND
ND
0.31
2
DAB-2B
ND
0.01
0.01
1.93
3
DAB Impurity-C
0.08
0.08
0.06
0.08
4
DAB Impurity-H
ND
0.04
0.04
0.25
5
DAB Impurity-D
ND
4.55
9.37
0.04
6
DAB Impurity-E
0.09
0.11
0.09
0.77
7
DAB Impurity-K
0.01
0.01
0.01
0.01
8
DAB Impurity-J
ND
0.03
0.01
0.27
9
DAB Impurity-G
0.04
0.05
0.03
0.71
10
Total unknown impurities
0.08
0.12
0.14
1.30
11
Total impurities
0.30
4.99
10.07
5.36
12
% of Degradation
NA
4.70
9.80
5.07
Table 3:
Result of Force Degradation study in Dabigatran etexilate mesylate
