| |
|
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 |
70.00 ± 0.000 |
84.46 ± 0.001 |
7.0 |
0.959 |
88.889 ± 0.207 |
0.988 ± 0.010 |
| 6th month |
appropriate |
47.8 ± 0.408 |
84.00 ± 0.000 |
6.5 |
0.381 |
62.963 ± 1.480 |
0.844 ± 0.010 |
| G1B |
t=0 |
appropriate |
70.50 ± 0.764 |
86.27 ± 0.001 |
7.0 |
0.939 |
82.405 ± 0.182 |
0.823 ± 0.000 |
| 6th month |
appropriate |
47.25 ± 0.418 |
86.30 ± 0.000 |
6.5 |
0.405 |
67.593 ± 1.52 |
0.802 ± 0.000 |
| G1C |
t=0 |
appropriate |
70.50 ± 0.836 |
84.56 ± 0.001 |
7.0 |
0.982 |
82.310 ± 1.263 |
0.823 ± 0.000 |
| 6th month |
appropriate |
46.60 ± 0.816 |
84.00 ± 0.000 |
6.5 |
0.595 |
76.130 ± 0.960 |
0.761 ± 0.000 |
| G4 |
Time |
|
|
|
|
|
|
|
| G4A |
t=0 |
appropriate |
150.5 ± 0.836 |
167.1 ± 0.002 |
13 |
0.276 |
86.574 ± 0.142 |
3.868 ± 0.010 |
| |
6th month |
appropriate |
164.6 ± 0.516 |
168.7 ± 0.001 |
12 |
0.551 |
82.407 ± 0.707 |
3.745 ± 0.042 |
| G4B |
t=0 |
appropriate |
150.5 ± 0.836 |
167.1 ± 0.001 |
13 |
0.143 |
86.111 ± 0.535 |
3.909 ± 0.000 |
| |
6th month |
appropriate |
164.1 ± 0.408 |
166.3 ± 0.001 |
12 |
0.343 |
83.333 ± 0.720 |
3.642 ± 0.040 |
| G4C |
t=0 |
appropriate |
150.0 ± 0.000 |
167.0 ± 0.001 |
13 |
0.096 |
83.796 ± 0.426 |
3.868 ± 0.010 |
| |
6th month |
appropriate |
166.0 ± 0.000 |
166.9 ± 0.000 |
12 |
0.372 |
83.796 ± 0.721 |
3.683 ± 0.040 |
|