| Forced Degradation Condition |
% Degradation |
% Impurity |
| Acid Hydrolysis: Exposure to acidic condition with 5M hydrochloric acid |
About 5.7% Degradation of carbidopa observed |
Methyldopa: About 1.16%
DHP: About 1.16%
Total Impurity: 5.34% |
| Base Hydrolysis: Exposure to basic condition with 5M sodium hydroxide |
About 5.5% Degradation of carbidopa observed |
Methyldopa: About 1.06%
DHP: About 3.18%
Total Impurity: 4.24% |
| Oxidative Degradation: Exposure to Oxidative condition with 3% hydrogen peroxide |
About 9.5% Degradation of carbidopa observed |
Methyldopa: About 1.20%
DHP: About 2.24%
Unknown Impurity about 6.5%
Total Impurity: 9.94% |
| Thermal Degradation: Exposure to 80°C for 24 hrs |
About 2.02% Degradation of carbidopa observed |
Methyldopa: About 2.83%
Total Impurity: 2.83% |
| Photostability: Exposure to UV Radiation NLT 1.2 million lux hours |
About 1.6% Degradation of carbidopa observed |
Methyldopa: About 2.13%
Total Impurity: 2.13% |
| Humidity Degradation: Exposure to 40°C temperature and 75% Relative humidity |
About 5.6% Degradation of carbidopa observed |
Methyldopa: About 2.7%
DHP: About 3.8%
Total Impurity: 6.5% |
