Table 1.
Outcome of stability studies performed on three batches of dihydroartemisinin tablets (Dynamax, Proxi Pharma, Belgium).
| Time | Assay | Disintegration | Dissolution | Uniformity of mass | Average weight | Appearance |
|---|---|---|---|---|---|---|
| Month | % | Minutes | % | |||
| (90-110) | (≤15) | (beige tablet) | ||||
| Batch n° A - Accelerated stability studies: 40°C and 75% RH | ||||||
| Zero | 97.4 | conform | 75 | conform | 0.2728 | conform |
| 1 | 99.3 | conform | 81 | conform | 0.2776 | conform |
| 3 | 80.4 | conform | 65 | conform | 0.2782 | not conform |
| Batch n° A - Real time stability studies: 30°C and 65% RH | ||||||
| Zero | 97.4 | conform | 75 | conform | 0.2728 | conform |
| 3 | 95.6 | conform | 70 | conform | 0.2769 | conform |
| 6 | 85.5 | conform | Not tested | conform | 0.2786 | conform |
| Batch n° B - Accelerated stability studies: 40°C and 75% RH | ||||||
| Zero | 91.7 | conform | 73 | conform | 0.2747 | conform |
| 1 | 93.9 | conform | 75 | conform | 0.2792 | conform |
| 3 | 77.3 | conform | 74 | conform | 0.2805 | not conform |
| Batch n° B - Real time stability studies: 30°C and 65% RH | ||||||
| Zero | 91.7 | conform | 73 | conform | 0.2747 | conform |
| 3 | 100.9 | conform | 67 | conform | 0.2775 | conform |
| 6 | 79.1 | conform | Not tested | conform | 0.2803 | conform |
| Batch n° C - Accelerated stability studies: 40°C and 75% RH | ||||||
| Zero | 93.7 | conform | 80 | conform | 0.2734 | conform |
| 1 | 95.0 | conform | 70 | conform | 0.2791 | conform |
| 3 | 88.4 | conform | 73 | conform | 0.2805 | not conform |
| Batch n° C - Real time stability studies: 30°C and 65% RH | ||||||
| Zero | 93.7 | conform | 80 | conform | 0.2734 | conform |
| 3 | 91.2 | conform | 68 | conform | 0.2785 | conform |
| 6 | 80.4 | conform | Not tested | conform | 0.2806 | conform |
Assay performed by HPLC with reference standard; appearance assessed by macroscopic inspection; disintegration, uniformity of mass and friability determined according to European Pharmacopoea.