Dissolution of Lamellae under Accelerated Incubation Conditions
| Temperature | Vial # | Time (h) | ||||
|---|---|---|---|---|---|---|
| 1 | 4 | 8 | 27 | 78 | ||
| 50 °C | 1 | − | + | + | + | − |
| 2 | − | − | + | + | − | |
| 3 | − | − | + | + | + | |
| 70 °C | 1 | − | + | − | − | − |
| 2 | − | + | + | − | − | |
| 3 | − | + | + | − | − | |
| 95 °C | 1 | + | − | − | − | − |
| 2 | − | − | − | − | − | |
| 3 | + | − | − | − | − | |
Washed and depyrogenated 95% alkalinity 3 cc vials (X95%) incubated at various temperatures after filling with 20 mM glycine pH 10. Visual Inspection was performed using APK unit. (+) lamellae detected; (−) no lamellae detected.