Component | Bulk drug sample batches | Formulation sample | |||
Batch No. 1 | Batch No. 2 | Batch No. 3 | Sample-1 | Sample-2 | |
Imp-1 | ND | ND | ND | 0.04 | 0.04 |
Imp-2 | 0.03 | ND | ND | ND | ND |
Imp-3 | ND | ND | ND | 0.03 | 0.03 |
Apixaban | 99.71 | 99.8 | 99.89 | 99.59 | 99.39 |
Imp-4 | 0.07 | 0.04 | 0.06 | ND | ND |
Imp-5 | ND | ND | ND | ND | ND |
Imp-6 | ND | 0.03 | ND | ND | ND |
Imp-7 | ND | ND | ND | ND | ND |
Imp-8 | ND | ND | ND | ND | ND |
Imp-9 | ND | ND | ND | 0.15 | 0.15 |