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CERTIFICATE OF ANALYSIS
PRODUCT NAME: LETROZOLE
BATICH NUMBER:20180620
MFG DATE:Jun.20,2018
TEST DATE:Jun.21,2018
EXP DATE:Jun.19,2020
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ANALYSIS |
SPECIFICATIONGS |
RESULTS |
|
ASSAY |
98.0-102.0% |
99.8% |
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CHEMICAL CONTROL |
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Identification |
IR HPLC UV |
Comform with standard IR Comform Comform |
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Related substances |
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Related substances A |
0.3%(max) |
0.04% |
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Any other impurity |
0.1%(max) |
0.04% |
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All other impurities |
0.3%(max) |
0.09% |
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Organic volatile impurities |
Conforms with ICH requirements |
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RESIDUAL SOLVENTS |
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Dichloromethane |
600ppm（max） |
Complies |
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Merhanol |
3000ppm（max） |
Complies |
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Acetone |
5000ppm（max） |
Complies |
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Ethanol |
5000ppm（max） |
Complies |
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PHYSICAL COMTROL |
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Description |
White to yellowish crystalline Powder |
Complies |
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Water by KF |
0.3%(max) |
0.1% |
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Residue on ignition |
0.1%(max) |
0.02% |
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Heavy metals |
0.001%(max) |
Complies |
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Storage conditions |
Cool and dry |
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(Conclusion):In conformity with USP36 |
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