Table 4.
The results of compatibility study by impurities analysis in HPLC.
| Items | Initial (%) | 4 Weeks (%) | |
|---|---|---|---|
| 25 °C/60 RH | 40 °C/75% RH | ||
| API | 0.39 | 0.41 | 0.42 |
| API + Capryol 90 | 0.40 | 0.46 | 0.53 |
| API + MCC | 0.39 | 0.46 | 0.43 |
| API + SSG | 0.45 | 0.39 | 0.41 |
| API + PVP | 0.48 | 0.40 | 0.42 |
| API + MS | 0.38 | 0.41 | 0.41 |
| API + CSD | 0.42 | 0.41 | 0.40 |
| API + SSF | 5.61 | 7.05 | 5.06 |
| API + SLS | 0.42 | 0.45 | 0.48 |
| API + Gelucire | 0.24 | 0.32 | 0.69 |
| API + Poloxamer | 0.31 | 0.58 | 0.36 |
| API + Citric acid | 0.60 | 0.75 | 0.52 |
| API + Calcium hydroxide | 2.06 | 2.21 | 3.40 |
Abbreviations: API, active pharmaceutical ingredient; SSF, sodium stearyl fumarate.