China Ondansetron HCl CAS No 103639-04-9, Find details about China 103639-04-9, Ondansetron HCl from Ondansetron HCl CAS No 103639-04-9
Items | Specifications | Results |
Appearance | White or off-white crystalline powder | Qualified |
Solubility | Sparingly soluble in water and in alcohol, Soluble in methanol, slightly soluble in isopropyl Alcohol conforms and dichloromethane, very slightly soluble in Acetone, in chloroform and in ethyl acetate. | Qualified |
Identification | ||
1.UV | Max 209,248,267,310nm | Qualified |
2.IR spectrum | Concordant with the working reference. | Qualified |
3.Discrimination chloride | Forward Reaction . | Qualified |
Water | 9.0-10.5% | 9.7% |
Residue on Ignition | ≤0.1% | 0.02% |
Heavy metal | ≤10ppm | <10ppm |
Compound D | ≤0.1% | 0.04% |
Chromatographic purity | ||
TLC max single impurity | ≤0.40% | 0.11% |
Other single impurity | ≤0.20% | 0.09% |
HPLC Impurity C | ≤0.20% | 0.09% |
Imidazole | ≤0.20% | 0.02% |
2-methylimidazole | ≤0.20% | 0.02% |
-Impurity A | ≤0.20% | 0.05% |
-Other single impurity | ≤0.10% | 0.07% |
-Total Impurity | ≤0.50% | 0.29% |
Residual solvent | ||
Ethanol | ≤5000ppm | 240ppm |
Assay | 98.0%~102.0% Calculates on the dried basis. | 99.81% |
CONCLUSION: CONFORM WITH SPECIFICATION AS PER USP40. |