Appearance | White or almost white crystals |
Solubility | Practically insoluble in water,freely soluble in ethanol (96 percent),soluble in trimethylpentane and in fatty oils |
Identification | IR Spectrum should be in accordance with that of cholecalciferol CRS HPLC should be consistent with the retention time of the main peak of the reference solution |
Specific Optical Rotation | +105.0° ~ +112.0 ° |
Assay | 98.0~102.0% (39,200,000~40,800,000IU/g) |
Resiudual Solvents | Methanol ≦ 3000ppm |
N-Hexane+2-methylpent ane+3-methylpentane ≦ 290ppm | |
Methyl formate ≦ 100ppm | |
Acetone ≦ 500ppm | |
Triethylamine ≦500ppm | |
Related Substances | A: Trans-vitamin D3 ≦0.1% |
B: Pro-vitamin D3 ≦ 0.10% | |
C: Lumisterol3 ≦ 0.10% | |
D: Iso-tachysterol3 ≦0.10% | |
E: Tachysterol3 ≦0.10% | |
Cholecalciferol butyrate ≦0.10% | |
Unspecified Impurities ≦ 0.10% | |
Total ≦1.0% | |
Heavy metals (as Pb) | ≦ 10ppm |
Arsenic | ≦ 1ppm |