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| Product | Anastrozole | ||||
| Batch No: | 181201 | Mfg.Date | 2018-12-01 | Analysis Date: | 2018-12-01 | 
| Quantity: | 10kg | CAS No.: | 120511-73-1 | Retest Date.: | 2020-11-30 | 
| ANALYSIS | SPECIFICATIONS | RESULTS | |||
| Appearance | White to off-white crystalline powder | Conforms | |||
| Solubiltity | Very soluble in acetronitrile,freely soluble in methanol,in acetone,in alcohol,and in tetrahydrofuran | Conforms | |||
| Identification | IR HPLC | Conform with standard IR Conforms | |||
| Water | NMT 0.3% | 0.1% | |||
| Residue on ignition | NMT 0.1% | Conforms | |||
| Heavy metals | NMT 10ppm | <10ppm | |||
| 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% | |||
| 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% | |||
| Assay (on dry basis) | 98.0%~102.0% | 99.7% | |||
| Conclusion:complies with USP35 | |||||
| STORAGE | Cool and dry | 
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| SHELF LIFE | 24 months | 
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