Duloxetine
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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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