Table 2 Overview of the dissolution test conditions.
API | Apparatus type | Medium | Rotation speed | Temperature | Testing time |
---|---|---|---|---|---|
AZM | Apparatus 2: Paddle | pH 6.0 buffer | 75 rpm | 37.0 °C ± 0.5 °C | 30 min |
CFIX | Apparatus 2: Paddle | pH 7.2 buffer | 100 rpm | 37.0 °C ± 0.5 °C | 45 min |
ESM | Apparatus 2: Paddle | Acid stage: 0.1 M HCl Buffer stage: pH 6.8 buffer | 100 rpm | 37.0 °C ± 0.5 °C | Acid stage: 120 min Buffer stage: 30 min |
LST | Apparatus 2: Paddle | Distilled, deaerated water | 50 rpm | 37.0 °C ± 0.5 °C | 30 min |