China Diabetes Drugs Gliclazide CAS No 21187-98-4, Find details about China Gliclazide, 21187-98-4 from Diabetes Drugs Gliclazide CAS No 21187-98-4
Items | Standard of quality | Results of analysis |
Characteristics | A white or almost white powder | A white powder |
Solubility | Practically insoluble in water;freely soluble in dichloromethane;sparingly soluble in acetone;slightly soluble in alcohol. | Meets the requirements |
Identification | The infrared absorption spectrum is concordant with the reference spectrum | Meets the requirements |
Impurity B | ≤2ppm | 0.1ppm |
Related substances | Impurity F ≤0.15% | Non-detected |
Other individual impurity≤0.10% | 0.03& | |
Total unknown impurity≤0.20% | 0.05% | |
Loss on drying | ≤0.25% | 0.2% |
Sulphated ash | ≤0.1% | 0.03% |
Residual Solvents | Ethyl acetate NMT 2500ppm | 175ppm |
Toluene NMT 890 ppm | Non-detected | |
Ethanol NMT 5000ppm | Non-detected | |
THF NMT 720ppm | Non-detected | |
Assay | 99.0%-101.0% | 99.7% |