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Table 13 Stability data trospium chloride ER tablets 60 mg

From: Development, optimization and pharmacokinetic evaluation of biphasic extended-release osmotic drug delivery system of trospium chloride for promising application in treatment of overactive bladder

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