Table 3.
Formulations | Drug Content (%) | Total Unknown Impurities (%) | ||||
---|---|---|---|---|---|---|
Initial | 3 Months | 6 Months | Initial | 3 Months | 6 Months | |
Accelerated stability test | ||||||
Diovan® | 100.1 ± 1.5 | 100.8 ± 2.8 | 99.7 ± 1.3 | BQL | BQL | 0.06 ± 0.01 |
S-SuSMED-T1 | 99.8 ± 1.0 | 99.8 ± 0.8 | 97.6 ± 2.2 | BQL | BQL | BQL |
S-SuSMED-T2 | 99.7 ± 0.9 | 99.5 ± 1.2 | 98.6 ± 1.5 | BQL | BQL | BQL |
Long-term stability test | ||||||
Diovan® | 100.1 ± 1.5 | 100.5 ± 1.9 | 99.9 ± 1.8 | BQL | BQL | BQL |
S-SuSMED-T1 | 99.8 ± 1.0 | 99.7 ± 1.7 | 98.8 ± 1.6 | BQL | BQL | BQL |
S-SuSMED-T2 | 99.7 ± 0.9 | 99.6 ± 1.2 | 99.2 ± 1.1 | BQL | BQL | BQL |
Values are presented as the mean ± SD (n = 6). BQL: below the quantification limit.