57808-66-9 Domperidone Motilium
CAS: | 57808-66-9 |
Name: | Domperidone |
Appearance:nce | white powder |
Application: | pharmaceutical |
Items |
Requirements |
Results |
Appearance |
White to off white powder |
White powder |
Solubility |
Practically insoluble in water, soluble in dimethylformamide, slightly soluble in ethanol(96%) and in methanol |
Confirms |
Identification |
A. M.P. 244~248℃ |
244.5~245.5℃ |
B. IR should comply |
Confirms |
|
C. TLC should comply |
Confirms |
|
D. It gives the reaction of non-nitrogen substituted barbiturates. |
Confirms |
|
Clarity of solution |
The solution is clear and not more intensely colored than reference solution Y6 |
Confirms |
Related substance |
Total impurities≤0.5% |
≤0.29% |
Individual impurity≤0.25% |
≤0.18% |
|
Loss on drying |
≤0.5% |
0.07% |
Sulphated ash |
≤0.1% |
≤0.05% |
Heavy metal |
≤20ppm |
<20ppm |
Assay |
99.0%~101.0% |
99.49% |
Conclusion: This product conforms to the EP7.0 detection. |
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