Table 3. Comparative stability profile of liposomal suspension and freeze-dried form of CL13 formulation as per ICH guidelines.
Test | Specification | Sample Name | Initial | 25 ± 2°C/ 60 ± 5% RH | 5 ± 3°C | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Time (months) | |||||||||||
1 | 2 | 3 | 6 | 1 | 2 | 3 | 6 | ||||
Assay (%w/w) | 95 to 105% | CL13 suspension | 99.52±0.42 | 98.88±0.31 | 97.73±0.26 | 96.67±0.37 | 94.69±0.51 | 98.73±0.43 | 98.33±0.39 | 97.92±0.34 | 95.85±0.43 |
CL13 freeze-dried product | 99.71±0.38 | 99.04±0.17 | 98.56±0.31 | 97.96±0.29 | 96.75±0.45 | 99.52±0.33 | 99.41±0.28 | 99.18±0.19 | 98.36±0.37 |
Data expressed as mean ± SD, n = 3