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BATCH NO.: HF161220 |
QUANTITY: 2.1kg |
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MFG. DATE : Dec. 20, 2016 |
PACKAGE: as required |
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REP. DATE : Dec. 26, 2016 |
EXP. DATE : Dec, 2018 |
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ITEMS |
STANDARDS |
RESULTS |
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Appearance |
White or light yellow crystalline powder |
Light yellow crystalline powder |
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Melting point |
183-188℃ |
186~188℃ |
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Feely soluble in methylene chloride,sparingly soluble in methanol, soluble in ethyl acetatate，Almost insoluble in water。 |
Complies |
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UV identification IR identification |
Complies Complies |
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Specific rotation |
+195.0°～+205.0° |
+198.0° |
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Related substances |
≤1.0% |
0.28% |
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Max unknown single impurity |
≤0.1% |
0.05% |
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Impurity A |
0.09% |
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Acetic acid |
≤0.5% |
N.D. |
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Loss on drying |
≤0.5% |
0.11% |
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Residue on ignition |
≤0.1% |
0.06% |
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Heavy metal |
≤10ppm |
Complies |
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Residual solvent |
THF ≤0.072％ |
N.D. |
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Ethyl acetate ≤0.5％ |
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Ethanol ≤0.5％ |
0.008% |
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2-propanol ≤0.5％ |
N.D. |
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Dichloromethanel ≤0.06％ |
0.004% |
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ASSAY |
≥98.5% |
99.6% |
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Conclusion：It complies to Enterprise standard. | |||
Ulipristal Acetate/126784-99-4