Product Name
|
Duloxetine
|
CAS No
|
116539-59-4
|
Catalog No
|
SC-19047
|
Quantity
|
10mg
|
Batch No
|
20130529
|
Product Date
|
2013.05.29
|
Date of analysis
|
2013.05.29
|
Items of analysis
|
Specification
|
Results
|
Appearance
|
White or off-white crystalline powder
|
White or off-white crystalline powder
|
Loss on drying
|
≤0.5%
|
0.19%
|
PH
|
3.4-4.5
|
4.0
|
Specific rotation
|
【α】25D=+118.0~+124.0(C=1.00,CH3OH)
|
【α】25D=+122.55 °(C=1.00,CH3OH)
|
Isomer
|
≤0.20%
|
0.26%
|
Residual solvents
|
Toluene: ≤890ppm
Isopropyl alcohol: ≤5000ppm
|
Complies
|
Residue on ignition
|
≤0.20%
|
0.08%
|
Assay
|
98.0%~102.0%
|
99.62%
|
Remark
|
Declaration: For laboratory use by technically qualified individual only
It is HCL salt form
|
|
Conclusion
|
It accords with the Enterprise Standard
|
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