|
ITEMS |
SPECIFICATION |
RESULTS |
|
Appearance |
White to off white microcrystalline powder |
Conforms |
|
Identification |
RT by HPLC conforms to CRS |
Conforms |
|
Solubility |
Very slightly soluble in water; Slightly soluble in methanol,Soluble in DMSO |
Conforms |
|
Water |
≤0.5% |
0.21% |
|
Loss on drying |
≤1.0% |
0.70% |
|
Residue on ignition |
≤0.1% |
0.04% |
|
Heavy metals |
≤10ppm |
Conforms |
|
Related substances |
Any single impurity≤0.10% |
0.09% |
|
|
Total impurities≤0.50% |
0.21% |
|
Residual solvents |
Methonal≤3000ppm |
200ppm |
|
|
Dichloromethane≤600ppm |
5ppm |
|
|
Toluene ≤890ppm |
5ppm |
|
|
Total solvents≤5000ppm |
10ppm |
|
(S)-Enantiomer |
≤0.1% |
0.02% |
|
Physical form |
Form II |
Conform by XRPD |
|
Particle size |
D(90)≤100μm |
62.38μm |
|
Bulk density |
For information only |
0.48 g/mL |
|
Tapped density |
For information only |
0.59 g/mL |
|
Assay (on anhydrous basis)
（
） |
98.0%~102.0% |
99.78% |
|
Storage Condition |
Sealed and stored in a dry place at room temperature. |
|
