Ropinirole 91374-21-9 Ropinirolum
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Test Item |
Analysis Specification |
Result |
Description |
White or pale yellow powder |
Conform |
Identification |
IR spectrum of the test sample corresponds to the IR spectrum of reference standard Positively responds to the test for chlorides. |
Conform |
Loss On Drying |
NMT0.5% |
0.26% |
Residue on ignition |
NMT0.1%. |
0.09% |
Related substance |
Individual known impurity NMT 0.15% Individual unknown impurity NMT 0.10% Total impurities NMT 1.0% |
0.098% 0.0081% 0.12% |
Content of chloride |
11.5%~12.5% |
11.71% |
Heavy metals |
NMT 20ppm |
Conform |
Assay |
98.0%~102.0%(calculated on the anhydrous basis) |
99.53% |
Residual solvents |
|
|
Acetone |
Not more than 5000ppm |
Not detected |
Ethyl acetate |
Not more than 5000ppm |
3690ppm |
Ethanol |
Not more than 5000ppm |
655ppm |
Toluene |
Not more than 890ppm |
Not detected |
N,N-Dimethylacetamide |
Not more than 1090ppm |
Not detected |
Conclusion |
Qualified |
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