Table 3.
Mean residual concentration (μg/mL), mean residual concentration (%), color changes, initial pH and post-study pH of 10 mg/mL and 50 μg/mL apomorphine HCl solutions (purged with nitrogen) after 168 hours
Experimental conditions | Experimental temperature (°C) | Mean residual concentration (%) at 168 hours* | Mean residual concentration at 168 hours | Color of solution at 168 hours | Initial pH | pH at 168 hours |
---|---|---|---|---|---|---|
Apomorphine HCl (10 mg/mL) in 0.1% SMB (buffered by acetate buffer) | 25 | 102.2 | 10.2 mg/mL | Colorless | 4.00 | 3.81 |
Apomorphine HCl (10 mg/mL) in 0.1% SMB (no buffer) | 25 | 100.0 | 10 mg/mL | Colorless | 2.71 | 2.27 |
Apomorphine HCl (50 μg/mL) in 0.1% SMB (buffered by acetate buffer) | 25 | 20.8 | 10.4 μg/mL | Colorless | 4.00 | 3.88 |
Apomorphine HCl (50 μg/mL) in 0.1% SMB (no buffer) | 25 | 41.8 | 20.9 μg/mL | Colorless | 3.44 | 3.04 |
Notes: Apomorphine HCl sample solutions for each assay were prepared in duplicate (n=2).
The acceptable limit of mean residual concentration at the end of period of stability study is between 95% and 105%.
Abbreviation: SMB, sodium metabisulfite.