|
|
Appearance
|
|
White or almost white power
|
|
Almost white power
|
|
|
Identification
|
|
The spectrum of the sample is in accordance with that of the reference standard
|
|
Conforms
|
|
|
Melting Point
|
|
177.0~184.0°℃
|
|
179.5～180.5℃
|
|
|
Specific rotation
|
|
-37.0~-42.0°
|
|
-40.6
|
|
|
Loss on drying
|
|
≤1.0%
|
|
0.10%
|
|
|
Related substances(HPLC) Benzyl alcohol
|
|
≤0.5%
|
|
0.06%
|
|
|
Related substances(HPLC) Single unknown impurity
|
|
≤0.10%
|
|
0.06%
|
|
|
Related substances(HPLC) Total sum of impurities
|
|
≤0.5%
|
|
0.12%
|
|
|
RRR-Enantiomer
|
|
≤2.0%
|
|
ND
|
|
|
Assay
|
|
98.0to102.0%
|
|
100.00%
|
|
|
Conclusion
|
|
Complies with Customer specification
|
|
|
