Table 5. Results of Forced Degradation Experiment.
| Forced Degradation Conditions | Degradation (%) | Mass Balance (%)a | Purity of Carglumic acid (%) |
|---|---|---|---|
| Untreated solution | - | - | 99.50 |
| Acid degradation (0.1 N HCl 2 h) | 11.6 | 98.1 | 99.08 |
| Alkali degradation (0.1 N NaOH 2 h) | 5.2 | 98.9 | 98.51 |
| Oxidative degradation (3% H2O2 1 h) | 8.6 | 99.5 | 99.41 |
| Thermal degradation (90 °C 21 days) | 7.6 | 98.3 | 99.35 |
| Photolytic degradation (1200 lx) | 1.2 | 99.9 | 99.47 |
| Accelerated stability condition (6 month 40° 75% Rh) | 0.33 | 98.5 | 99.04 |
a
Mass balance equation; % assay of stressed sample + %impurities × 100/% assay of unstressed sample.