Table I.
Tablet | L-1 | L-2 | L-3 | L-4 | L-5 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Whole | Hand | Splitter | Whole | Hand | Splitter | Whole | Hand | Splitter | Whole | Hand | Splitter | Whole | Hand | Splitter | |
1 | 103.2 | 110.0 | 111.9 | 106.5 | 100.4 | 101.4 | 100.0 | 100.2 | 111.1 | 77.5 | 89.6 | 91.4 | 98.1 | 84.5 | 88.2 |
2 | 102.7 | 97.5 | 89.9 | 101.1 | 102.4 | 84.2 | 97.3 | 101.8 | 80.2 | 79.8 | 83.1 | 78.4 | 103.6 | 118.9 | 99.5 |
3 | 102.7 | 95.8 | 111.5 | 101.7 | 105.2 | 98.9 | 97.8 | 92.8 | 109.1 | 81.5 | 90.7 | 82.5 | 98.7 | 104.1 | 93.3 |
4 | 102.6 | 118.4 | 90.9 | 98.3 | 97.4 | 85.7 | 97.3 | 110.2 | 90.8 | 79.3 | 80.2 | 81.9 | 101.2 | 88.9 | 101.9 |
5 | 102.4 | 115.9 | 118.0 | 100.0 | 99.6 | 102.0 | 99.2 | 96.2 | 110.1 | 77.9 | 82.1 | 81.2 | 102.0 | 99.0 | 100.8 |
6 | 100.6 | 91.0 | 92.7 | 97.4 | 100.3 | 86.5 | 99.2 | 104.0 | 82.2 | 81.5 | 92.9 | 87.2 | 102.7 | 100.3 | 92.5 |
7 | 104.0 | 97.3 | 114.3 | 99.2 | 95.7 | 93.3 | 99.6 | 105.2 | 106.5 | 81.7 | – | 88.0 | 101.6 | 93.0 | 104.3 |
8 | 106.2 | 110.1 | 95.1 | 99.1 | 112.0 | 93.7 | 100.5 | 95.9 | 95.5 | 78.4 | 83.5 | 80.5 | 99.8 | 110.3 | 96.8 |
9 | 103.2 | 99.4 | 119.4 | 100.0 | 94.8 | 101.4 | 99.9 | 100.2 | 106.0 | 83.6 | 79.3 | 76.7 | 102.7 | 102.3 | 100.1 |
10 | 102.3 | 108.0 | 89.9 | 100.3 | 98.4 | 97.9 | 100.7 | 101.8 | 87.2 | 87.1 | 88.4 | 74.4 | 101.1 | 92.0 | 94.5 |
Mean | 103.0 | 104.3 | 103.4 | 100.4 | 100.6 | 94.5 | 99.1 | 100.8 | 97.9 | 80.8 | 85.5 | 82.2 | 101.2 | 99.3 | 97.2 |
Stdev | 1.4 | 9.3 | 12.6 | 2.5 | 5.0 | 6.9 | 1.3 | 5.0 | 12.1 | 2.9 | 4.7 | 5.3 | 1.8 | 10.3 | 5.0 |
% CV | 1.4 | 8.9 | 12.2 | 2.5 | 5.0 | 7.3 | 1.3 | 5.0 | 12.4 | 3.6 | 5.4 | 6.5 | 1.8 | 10.4 | 5.2 |
The assay values presented as italic bold red fonts represent the failure to meet specification of 90.0% to 110.0% of assay value. All the whole tablets except L-4 met the specification, however, failures were observed for both hand- and splitter- split portions for all the marketed tablets