Gliclazide CAS 21187-98-4
Test items |
Standard Code |
Results |
Appearance |
A white or almost white powder |
A white powder |
Solubility |
Practically insolubleinwater, freely soluble in dichloromethane;sparingly soluble in acetone,sightly soluble in alcohol |
Meet the requirement |
Identification |
The infrared absorption spectrum is concordant with the reference spectrum |
Meet the requirement |
Impurity B |
≤2ppm |
0.12ppm |
Related substance |
Impurity F≤0.15% |
Non-detected |
|
Otherindividual inpurity≤0.10% |
0.05% |
|
Total unknown impurity≤0.20% |
0.09% |
Loss on drying |
≤0.25% |
0.09% |
Sulphated ash |
≤0.1% |
0.06% |
Residual Solvents |
Ethyl acetate NMT≤2500ppm |
303ppm |
|
Toluene NMT≤890ppm |
Non-detected |
|
Ethanol NMT≤5000ppm |
Non-detected |
|
THF NMT≤720ppm |
Non-detected |
Assay |
99.0%-101.0% |
99.8% |
Conclusion |
The test results conform with EP9.0 |