Table 1.
Long term stability data according to ICH Q5C guidelines for biotechnological products. Content values are expressed as mean ± SD.
| Property | 0 months | 3 months | 6 months | 12 months | |
|---|---|---|---|---|---|
| 1. | Particle Size | 297.3 nm | 296.5 nm | 296.1 nm | 293.6 nm |
| 2. | Quillaja Saponin content | 103.49 ± 0.26 μg | 97.22 ± 0.52 μg | 101.53 ± 0.87 μg | 95.45 ± 0.25 μg |
| 3. | LPS content | 57.03 ± 1.52 μg | 58.67 ± 1.14 μg | 52.87 ± 2.05 μg | 56.33 ± 4.06 μg |