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Phenylephrine
Test Items | Specification | Results |
Characteristic | White or almost white, crystalline powder | White crystalline powder |
Identification A Identification B | Positive identification | Complies |
Positive identification | Complies | |
Melting point | 140 to 145 | 142.1 ~143.1 |
Specific Rotation | -42 to -47.5 | -45.4° |
Chromatographic purity | Individual impurity ≤0.5 % Sum of impurities ≤ 1.0% | Complies |
Limit of Ketones | No deeper than the control solution | Complies |
Sulfates | Not more than 2000 ppm | Complies |
Loss on Drying | Not more than 1.0 % | 0.07% |
Residue on Ignition | Not more than 0.2 % | 0.01% |
Chloride content | 17.0% to 17.7% | 17.5% |
Assay | 97.5% to 102.5 % | 99.9% |
Particle Size | 98% past 40 Mesh | Complies |
Residual Solvents | Methanol ≤3000 ppm | 68 ppm |
2-Propanol ≤5000 ppm | 93 ppm | |
Ethanol ≤5000 ppm | ND | |
Package and Storage | Preserve in tight and light-resistant containers Store at 25°C. Excursion permitted between 15°C to 30°C | |
| Conclusion | The product meets the requirements of USP31 | |
Phenylephrine