Table 2 Physicochemical parameters of lyophilized and reconstituted drug substance and placebo
Test | PBMCsec 1 | PBMCsec 2 | PBMCsec 3 | placebo |
|---|---|---|---|---|
Appearance of lyophilisate | White, no color deviations or discolorations, amorphous, homogenous | White, no color deviations or discolorations, amorphous, homogenous | White, no color deviations or discolorations, amorphous, homogenous | White, no color deviations or discolorations, amorphous, homogenous |
Dissolution time | 65 s | 45 s | 38 s | 34 s |
Color of reconstituted solution | Between reference solution GY5 and GY6 | Between reference solution GY5 and GY6 | Equivalent to reference solution GY5 | Between reference solution GY5 and GY6 |
Clarity and degree of opalescence | Clear, less than reference suspension 1 (3 NTU) | Clear, less than reference suspension 1 (3 NTU) | Clear, less than reference suspension 1 (3 NTU) | Clear, less than reference suspension 2 (6 NTU) |
Water content | 2.6% | 2.6% | 3.0% | 2.2% |
pH | 8.4 | 8.6 | 8.6 | 8.8 |
Osmolality | 1.4 osmol/kg | 1.4 osmol/kg | 1.4 osmol/kg | 1.4 osmol/kg |
Visible particles | 0 against white background, 0 against black background | 0 against white background, 0 against black background | 0 against white background, 0 against black background | 0 against white background, 0 against black background |