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CERTIFICATE OF ANALYSIS
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Product Name |
Domperidone |
Batch No. |
230602 |
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Manu. Date |
2023.06.02 |
Anal. Date |
2023.06.02 |
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Test Basis |
EP7.0 |
Factory lot number |
20230602 |
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Appearance |
White or almost white powder |
White powder |
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Solubility |
Practically insoluble in water, soluble in dimethyl formamide, slightly soluble in alcohol and in methanol |
Complies |
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Identification |
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A）M.P. |
244-248℃ |
244-246℃ |
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B）TLC Method |
Shall comply |
Complies |
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C）Non Nitrogen Substituted Barbiturate |
Shall comply |
Complies |
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Appearance of the solution |
Shall comply |
Complies |
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Related substance |
By HPLC, individual impurity≤0.25% |
0.051%,0.058%,0.201% |
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Total impurity≤0.5% |
0.312% |
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Heavy metals |
Not more than 20ppm |
Complies |
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Loss on drying |
≤0.50% |
0.13% |
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Residue on ignition |
≤0.1% |
0.06% |
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Assay |
99.0% -101.0% |
99.75% |
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Conclusion |
Conform to EP7.0/USP35 |
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