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Product Name |
Fluticasone propionate |
Batch No. |
20200407 |
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MFG. Date |
Apr.01,2020 |
EXP. Date |
Apr.01,2022 |
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Package |
100g/bag |
Batch quantity |
50KG |
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Description |
White or almost white ,crystalline powder |
Almost white crystalline powder |
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Solubility |
Practically insoluble in water,sparingly soluble methylene chloride,slightly soluble in ethanol(96perceng) |
Conforms |
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Identification |
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IR |
A: Theinfrared absorption spectrum of test sample should conform to that of reference standard. |
Conforms |
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HPLC |
B:The principal peak in the chromatogram obtained with the test solution is similar in retention time to reference standard. |
Conforms |
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Specific optical rotation |
+32°~ +36° |
+35° |
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Water |
≤0.5% |
0.1% |
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Related substances |
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Impurity A |
≤0.2% |
0.02% |
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Impurity B |
≤0.2% |
0.05% |
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Impurity C |
≤0.2% |
0.08% |
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Impurity D |
≤0.3% |
0.2% |
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Impurity E |
≤0.2% |
＜0.02% |
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Impurity F |
≤0.2% |
＜0.02% |
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Impurity G |
≤0.3% |
0.06% |
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Impurity H |
≤0.2% |
0.06% |
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Impurity I |
≤0.2% |
0.02% |
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Any Impurity |
≤0.1% |
0.05% |
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Total impurity |
≤1.2% |
0.79% |
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Acetone |
≤1.0% |
Conforms |
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Assay |
97.0%～102.0% |
99.7% |
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Conclusion |
Complies with EP8.0 |
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