Table 3 Parameters of the lyophilization process of reagents kits for the preparation of radiopharmaceutical based on glucose derivatives.
From: 99mTc-labeled monosaccharide kits: development methods and quality control
Name of the parameter | RP “5-thio-D-glucose, 99mТс” | RP “1-thio-D-glucose, 99mТс” | RP «“D- glucosamine, 99mТс” |
|---|---|---|---|
Volume of mixture in 1 flask | Not more than 1 ml | Not more than 1 ml | Not more than 1 ml |
Pre-freezing | no | 2 h (−50 °С) | 2 h (−50 °С) |
Vacuum level of lyophilization | 0.2 Pa | 0.2 Pa | 0.2 Pa |
Lyophilization temperature | −50 °С | −50 °С | −50 °С |
Time of lyophilization, h | 24 | 22 | 21 |
Temperature in the upper drying chamber | +10 °С + 15 °С | +10 °С + 15 °С | +10 °С + 15 °С |
Drying time in the upper lyophilic chamber, h | 4.0 | 5.0 | 5.5 |
