东康源120511-73-1质检单/质量标准/COA
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Product |
Anastrozole |
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Batch No: |
181201 |
Mfg.Date |
2018-12-01 |
Analysis Date: |
2018-12-01 |
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Quantity: |
10kg |
CAS No.: |
120511-73-1 |
Retest Date.: |
2020-11-30 |
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ANALYSIS |
SPECIFICATIONS |
RESULTS |
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Appearance |
White to off-white crystalline powder |
Conforms |
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Solubiltity |
Very soluble in acetronitrile,freely soluble in methanol,in acetone,in alcohol,and in tetrahydrofuran |
Conforms |
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Identification |
IR HPLC |
Conform with standard IR Conforms |
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Water |
NMT 0.3% |
0.1% |
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Residue on ignition |
NMT 0.1% |
Conforms |
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Heavy metals |
NMT 10ppm |
<10ppm |
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Related substances Related Compound B Related Compound C Related Compound D Related Compound E Individual unspecified impurity Total unspecified impurity Total impurities |
NMT 0.2% NMT 0.2% NMT 0.1% NMT 0.1% NMT 0.1%
NMT 0.1% NMT 0.5% |
ND ND ND 0.05% 0.07%
0.08% 0.2% |
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Residual solvents Dichloromethane Chloroform Ethanol Cyclohexane Ethylacetate |
NMT 0.06% NMT 0.006% NMT 0.5% NMT 0.08% NMT 0.5% |
ND ND 0.07% ND 0.1% |
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Assay (on dry basis) |
98.0%~102.0% |
99.7% |
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Conclusion:complies with USP35 |
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STORAGE |
Cool and dry |
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SHELF LIFE |
24 months |
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