Table III.
Stability of pDERMATT 2 mg/Vial Lyophilised in 20 mg/ml Sucrose after Storage at 2–8°C
| Storage time (months) | Content (%) | SC Purity (%) | Residual moisture (%) |
|---|---|---|---|
| 0 | 99.6 | 98.4 | 0.7 (± 0.07) |
| 3 | 98.0 | 98.5 | nd |
| 6 | 100.8 | 96.2 | 1.96 (± 0.51) |
| 9 | 98.7 | 96.9 | nd |
| 12 | 98.4 | 96.3 | 2.20 (± 0.01) |
| 18 | 96.9 | 97.4 | nd |
| 24 | 97.4 | 99.0 | 2.39 (± 0.09) |
nd not determined