Appearance Disintegration time ( sec ) Average weight (mg) Hardness (kp) Friability ( % ) Dissolution (% ) Amount (mg/tablet)     Specification limits oblonged shaped. notched max. 30’ G1: 85±7.5% G4: 170 ± 7.5% ± 3.5% max. 1% min. 80% (at 15’) G1: 0.85-1.15 G4: 3.4–4.6 G1 Time               G1A t=0 appropriate 70.0 ± 0.000 84.46 ± 0.001 7.0 0.959 88.889 ± 0.207 0.988 ± 0.010   appropriate 49.9 ± 0.000 84.60 ± 0.001 7.0 0.212 77.778 ± 0.200 0.700 ± 0.032 6th month appropriate 46.7 ± 0.816 84.56 ± 0.001 6.5 1.361 75.924 ± 0.142 0.761 ± 0.030 G1B t=0 appropriate 70.5 ± 0.764 86.27 ± 0.001 7.0 0.939 82.407 ± 0.182 0.823 ± 0.000   appropriate 50.0 ±0.204 86.30 ± 0.001 7.0 0.242 84.259 ± 0.183 0.720 ± 0.028 6th month appropriate 48.1 ± 0.480 84.50 ± 0.001 6.5 1.290 80.556 ± 0.150 0.792 ± 0.024 G1C t=0 appropriate 70.5 ± 0.836 84.56 ± 0.001 7.0 0.982 75.924 ± 1.263 0.823 ± 0.000   appropriate 50.1 ± 0.204 86.40 ± 0.001 7.0 0.301 90.740 ± 0.192 0.720 ± 0.030 6th month appropriate 50.1 ± 0.850 84.50 ± 0.001 6.5 1.112 85.185 ± 0.150 0.823 ± 0.036 G4 Time               G4A t=0 appropriate 150.5 ± 0.836 167.1 ± 0.002 13.0 0.276 86.574 ± 0.142 3.868 ± 0.010   appropriate 162.5 ± 0.836 167.3 ± 0.002 11.5 0.335 84.722 ± 0.122 3.868 ± 0.037 6th month appropriate 162.5 ± 0.836 166.1 ± 0.001 12.5 0.572 83.333 ± 0.920 3.786 ± 0.025 G4B t=0 appropriate 150.5 ± 0.836 167.1 ± 0.001 13.0 0.143 86.111 ± 0.535 3.909 ± 0.000   appropriate 162.5 ± 0.836 167.1 ± 0.001 11.5 0.186 84.722 ± 0.120 3.807 ± 0.021 6th month appropriate 162.5 ± 0.836 166.8 ± 0.001 12.5 0.659 84.259 ± 0.800 3.724 ± 0.045 G4C t = 0 appropriate 150.5 ± 0.000 167.0 ± 0.001 13.0 0.143 83.796 ± 0.426 3.868 ± 0.010   appropriate 162.0 ± 1.549 167.0 ± 0.001 11.5 0.120 86.574 ± 0.080 3.765 ± 0.040 6th month appropriate 162.5 ± 1.549 167.5 ± 0.001 12.5 0.363 85.185 ± 0.860 3.786 ± 0.040

Table 4: Long term stability test results of G1 and G4 of three different batches.