Parameters | Brand ALT1 | Brand AMT2 | Brand AMT3 | Brand AST4 | Standard Specifications | Remarks |
Description & Packaging | Round, white, Alu Alu | Octahedral, White, Alu PVC | Round, White, Alu PVC | Round, Orange, Alu PVC | - | - |
Average Weight (mg) Mean ± SD | 70.15 ± 1.22 | 137.28 ± 2.20 | 160.23 ± 3.74 | 168.25 ± 4.91 | − | − |
Weight Variation (%) | (−) 2.21 to (+) 3.78 | (−) 3.56 to (+) 1.83 | (−) 3.82 to (+) 5.47 | (−) 7.34 to (+) 5.02 | ± 10% (≤ 130 mg) ± 7.5% (130 - 324 mg). | Comply |
Hardness Test (kg) Mean ± SD | 3.60 ± 0.48 | 9.52 ± 1.85 | 2.29 ± 0.15 | 3.12 ± 0.72 | − | − |
Friability Test (%) | 0.007 | 0.08 | 0.02 | 0.006 | 0.5% to 1% | Comply |
Thickness Test (%) | (−) 1.12 to (+) 1.80 | (−) 2.76 to (+) 2.34 | (−) 4.57 to (+) 2.92 | (−) 0.99 to (+) 0.94 | ± 5% | Comply |
Loss on Drying | 4.45% | 4.75% | 6.17% | 5.27% | − | − |
Disintegration Time | 23 sec | 36 sec | 3 min 3 sec | 2 min 43 sec | Within 30 minutes | Comply |
% Dissolved in 30 min. | 95.34% | 92.33% | 84.29% | 92.49% | Minimum 75% in 30 min | Comply |
Assay (%) ± SD | 105.15 ± 0.34 | 104.15 ± 0.22 | 103.89 ± 1.05 | 105.53 ± 1.77 | 90% − 110% | Comply |