Table 13 Stability data trospium chloride ER tablets 60 mg
Batch no. TSP-18 | Packing: 10's tablets in blister pack | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Sr. no | Tests | Specification | Initial | 40 °C ± 2 °C and 75% ± 5% RH | 25 °C ± 2 °C and 60% ± 5% RH | |||||
1 M | 2 M | 3 M | 6 M | 3 M | 6 M | 12 M | ||||
1 | Description | Transparent/Translucent White and yellow colored bi-layered round biconvex tablet with preformed passageway at the center of the white layer side of tablet | No change | No change | No change | No change | No change | No change | No change | No change |
2 | Assay (%) | NLT 90% and NMT 110% | 101.1 | 101 | 100.2 | 100.0 | 98.2 | 101 | 99.8 | 99.2 |
3 | Dissolution (% drug release) | |||||||||
2 h | NMT 30% | 20 | 18 | 22 | 25 | 19 | 20 | 19 | 17 | |
5 h | Between 35 and 50% | 42 | 43 | 39 | 45 | 43 | 39 | 43 | 39 | |
11 h | Between 55 and 75% | 66 | 65 | 67 | 71 | 63 | 68 | 65 | 62 | |
20 h | NLT 85% | 97 | 96 | 97 | 98 | 99 | 101 | 100 | 99 | |