Table 2. Evaluation of the weight uniformity of the half or quarters of tablet adopting the USP test of uniformity of dosage units.
Fraction of tablet | Pharmaceutical products | Tablets (n) |
Number of units with weight between 85% ≤ mass ≤ 115% (n) | Number of units with weight between 75% ≤ mass ≤ 125% (n) | Number of units with weight exceeding the limit ± 25%, mass ≥ 25% (n) | RSD% | Acceptability |
---|---|---|---|---|---|---|---|
Libeo 10 mg L2 | 10 | 10 | 0 | 0 | 3.3 | Compliant | |
Furosoral 40 mg | 10 | 5 | 3 | 2 | 16 | Not compliant | |
30 | 20 | 7 | 3 | 15 | Not compliant | ||
Furosoral 10 mg | 10 | 6 | 3 | 1 | 16 | Not compliant | |
30 | 23 | 3 | 4 | 17 | Not compliant | ||
Diuren 20 mg L1 | 10 | 2 | 6 | 2 | 23 | Not compliant | |
30 | 20 | 6 | 10 | 15 | Not compliant | ||
Libeo 10 mg L2 | 10 | 10 | 0 | 0 | 3.4 | Compliant | |
Furosoral 40 mg | 10 | 6 | 3 | 1 | 14 | Not compliant | |
30 | 23 | 5 | 2 | 9 | Not compliant | ||
Furosoral 10 mg | 10 | 9 | 1 | 0 | 7.7 | Not compliant | |
30 | 27 | 3 | 0 | 4.9 | Not compliant | ||
Diuren 20 mg L1 | 10 | 2 | 6 | 2 | 18 | Not compliant | |
30 | 20 | 6 | 4 | 13 | Not compliant | ||
Dimazon 40 mg L1 | 10 | 10 | 0 | 0 | 5.7 | Compliant | |
L.F.M. 25 mg | 10 | 6 | 3 | 1 | 16 | Not compliant | |
30 | 22 | 4 | 4 | 10 | Not compliant | ||
DOC 25 mg | 10 | 9 | 1 | 0 | 9.8 | Not compliant | |
30 | 29 | 1 | 0 | 6.3 | Not compliant | ||
Teva 25 mg L3 | 10 | 8 | 2 | 0 | 14 | Not compliant | |
30 | 27 | 2 | 1 | 8.7 | Not Compliant | ||
Teva 25 mg L2 | 10 | 10 | 0 | 0 | 2.9 | Compliant | |
Mylan 25 mg L3 | 10 | 10 | 0 | 0 | 4.8 | Compliant | |
Mylan 25 mg L2 | 10 | 9 | 1 | 0 | 8.6 | Not compliant | |
30 | 29 | 1 | 0 | 5.5 | Compliant | ||
Lasix 25 mg L3 | 10 | 8 | 2 | 0 | 12 | Not compliant | |
30 | 26 | 4 | 0 | 9.9 | Not compliant | ||
Lasix 25 mg L2 | 10 | 7 | 3 | 0 | 12 | Not compliant | |
30 | 25 | 5 | 0 | 7.4 | Not compliant |