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