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% |
For customer reference only.
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