Non-Isothermal (LNISO) Stability | Abbreviated Isothermal Stability | Conventional Isothermal Stability | |
---|---|---|---|
Drug Substance Concentration | 40 ppm | 40 ppm | 40 ppm |
Vehicle | 80:20 (~30 mM Phosphate Buffer/Ethanol) | 80:20 (~30 mM Phosphate Buffer/Ethanol) | 80:20 (~30 mM Phosphate Buffer/Ethanol) |
Target pH | Starting pH: 7.0, End pH: shifted by ≤ 0.2 pH-unit due to the temp. increase | 7.0 | 7.0 |
Heating Type/Storage Temperatures | Linear Heating (50 – 95 °C) | Isothermal (50, 60, and 80 °C) | Isothermal (40, 50, 60, and 80 °C) |
Target Time Points | 0, 8, 32, 56, 80, 104, 120, 128, 144, 152, 168 h | 0, 3, 7, 14 and 28 days | 0, 3, 7, 14, 28, 42 and 56 days |
Sample Storage Time | 7 days | 4 weeks | 8 weeks |
Total Number of Samples | 11 | 13 | 25 |