Table 5.
Environment | Conditions | C0, μg/mL | Ct, μg/mL | % Decomposition | ICH Classification |
---|---|---|---|---|---|
2 | |||||
HCl | 0.1 M, 90 °C, 16 h | 61.3 | 5.0 | 91.8 | |
HCl | 0.01 M, 40 °C, 8 h | 60.0 | 33.7 | 43.8 | very unstable |
NaOH | 0.1 M, 90 °C, 16 h | 61.3 | 0 | 100 | |
NaOH | 0.01 M, 25 °C, 2 h | 60.0 | 0 | 100 | extremely unstable |
H2O | 90 °C, 24 h | 61.3 | 46.3 | 24.4 | unstable |
H2O2 | 1%, 30 min | 30.0 | 29.9 | <0.5 | |
H2O2 | 3%, 24 h | 30.0 | 29.8 | <0.5 | |
H2O2 | 10%, 24 h | 30.0 | 30.1 | <0.5 | practically stable |
6 | |||||
HCl | 0.1 M, 90 °C, 16 h | 66.9 | 1.5 | 97.8 | |
HCl | 0.01 M, 40 °C, 8 h | 60.0 | 49.3 | 17.8 | very unstable |
NaOH | 0.1 M, 90 °C, 16 h | 66.9 | 0 | 100 | |
NaOH | 0.01 M, 25 °C, 2 h | 60.0 | 0 | 100 | extremely unstable |
H2O | 90 °C, 24 h | 66.9 | 50.9 | 23.9 | unstable |
H2O2 | 1%, 30 min | 30.0 | 29.7 | <0.5 | |
H2O2 | 3%, 24 h | 30.0 | 29.9 | <0.5 | |
H2O2 | 10%, 24 h | 30.0 | 30.0 | <0.5 | practically stable |