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CERTIFICATE OF ANALYSIS
PRODUCT NAME：KETOTIFEN FUMARATE
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Batch No.: |
20201102 |
Date of Manufature |
2020.11.02 |
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Batch Size |
30kg |
Certificate Date |
2020.11.02 |
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Specification |
EP Ⅳ |
Date of Expiry |
2022.11 |
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Test |
Specification |
Results |
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Appearance |
White to brownish-yellow,fine,crystalline powder |
Complies |
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Solubility |
Sparingly soluble in water , slightly soluble in Methanol , very slightly soluble in acetonifrile |
Complies |
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Identification |
TLC |
Complies |
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IR spectrum |
Complies |
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Clarity and colour of solution |
Clear and not more than Y4BY4B4 |
＜BY4 |
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Loss on drying |
Not more than 0.5% |
0.20% |
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Sulphated ash |
Not more than 0.1% |
0.02% |
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Related substances(HPLC) Impurity A Impurity G Single unknown impurity Total impurities |
Not more than 0.2% Not more than 0.2% Not more than 0. 15% Not more than 0.5% |
N.D 0.07% N.D 0.07% |
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Residual solvents |
Acetone≤5000ppm Methanol≤500ppm |
1750ppm ＜1ppm |
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Assay(potetiometic titration) Calculated on the dried basis |
Between 98.5% and 101.0% |
99.55% |
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Conclusion |
Complies |
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