| Test |
Specification |
Actual value |
| Assay (by GC) | min. 99.9 % | 100.0 % |
| Residue after Evaporation | max. 1 ppm | < 1 ppm |
| Water (H2O) | max. 0.01 % | 0.001 % |
| LC-Gradient-Diode Array Detection (AU), test solution is modified with 0.1% (v/v) formic acid: | | |
| at 220 nm | max. 0.002 | < 0.002 |
| at 254 nm | max. 0.001 | < 0.001 |
| LC-MS Gradient Suitability Test (TIC, 100 to 2000 m/z), test solution is modified with 0.1% (v/v) formic acid: | | |
| Positive ESI-MS Sensitive Impurities (as Reserpine) | max. 50 ng/ml | < 50 ng/ml |
| Trace Impurities (in ppb) | | |
| Aluminium (Al) | max. 50 | < 50 |
| Calcium (Ca) | max. 50 | < 50 |
| Iron (Fe) | max. 50 | < 50 |
| Magnesium (Mg) | max. 50 | < 50 |
| Potassium (K) | max. 50 | < 50 |
| Sodium (Na) | max. 50 | < 50 |
| Ultraviolet Absorbance (1.00-cm path vs water): | | |
| at 200 nm | max. 0.05 | 0.01 |
| at 220 nm | max. 0.01 | < 0.01 |
| at 254 nm | max. 0.01 | < 0.01 |
