| Name of impurity |
LOQ (%w/w) |
Area of inj. -1 |
Area of inj. -2 |
Area of inj. -3 |
Area of inj. -4 |
Area of inj. -5 |
Area of inj. -6 |
% RSD |
| DAB Impurity-A |
0.03 |
5432 |
5435 |
5448 |
5420 |
5541 |
5547 |
1.05 |
| DAB-2B |
0.03 |
3759 |
3720 |
3670 |
3626 |
3653 |
3633 |
1.43 |
| DAB Impurity-C |
0.03 |
3760 |
3750 |
3716 |
3843 |
3750 |
3656 |
1.64 |
| DAB Impurity-H |
0.03 |
4608 |
4635 |
4669 |
4451 |
4563 |
4514 |
1.77 |
| DAB Impurity-D |
0.03 |
3388 |
3488 |
3349 |
3327 |
3373 |
3428 |
1.71 |
| DAB Impurity-E |
0.03 |
4002 |
3873 |
3767 |
3896 |
3821 |
3893 |
2.04 |
| DAB Impurity-K |
0.03 |
3953 |
3892 |
3824 |
3949 |
4069 |
4035 |
2.28 |
| DAB Impurity-J |
0.03 |
3403 |
3358 |
3504 |
3331 |
3443 |
3478 |
1.99 |
| DabigatranEtexilateMesylate |
0.03 |
2910 |
2883 |
2805 |
3031 |
2907 |
3032 |
3.03 |
| DAB Impurity-G |
0.03 |
6703 |
6792 |
6804 |
6789 |
6989 |
6899 |
1.46 |
|
