Appearance A white to off white solid
Identification A.HPLC:RRT test solution is similar to
RRT reference solution
B.IR: similar to reference substance
Specific rotation -8°~ -12°
Chlorides Not more than 100ppm
Loss on drying Not more than 2.0%
Sulfated ash Not more than 0.1%
metals Not more than 10ppm
Related substances ALD3 Not more than 0.15%
ALD2 Not more than 0.15%
TK1-10 Not more than 0.15%
TK1-9 Not more than 0.15%
Any other individual impurity ≤0.10%
Total impurities ≤1.0%
Enantiomer Not more than 0.15%
Acetates Not more than 3000ppm
Residual solvents Methanol 3000ppm max
Ethanol 5000ppm max
Ethyl ethe 5000ppm max
Isopropanol 5000ppm max
Acetonitrile 410ppm max
Dichloromethane 600ppm max
Tert-butyl methyl ethe 5000ppm max
Hexane 290ppm max
Isopropyl ethe 5000ppm max
Ethyl acetate 5000ppm max
Tetrahydrofuran 720ppm max
1,4-Dioxane 380ppm max
Toluene 890ppm max
Assay 98.0~102.0%(on the dried basis)
