TEST
|
SPECIFICATION
|
RESULTS
|
Appearance
|
Light yellow or yellow crystalline powder
|
Light yellow crystalline powder
|
Melting point
|
116。C -121。C
|
117.2。C - 118.0。C
|
Specific optical rotation
|
-69。- -75。
|
-74.3。
|
Identification
A.The retention time of HPLC
B. IR
|
Examine the chromatograms obtained in the assay: the retention time to the principal peak in the chromatograms obtained with the rest solution is similar in retention time to the principal peak in the chromatograms obtained with reference solution
The IR spectrum of the sample is same as the reference standard.
|
Conform
Conform
|
Related substances
Impurity A
Impurity C
Any unspecified impurity
Total impurities
|
≤ 0.5%
≤ 0.5%
≤ 0.20%
≤ 2.0%
|
0.19%
Not detected
Not detected
0.19%
|
Loss on drying
|
≤ 0.5%
|
0.07%
|
Residue on ignition
|
≤0.20%
|
0.05%
|
Assay
|
98.0%-102.0% (on the dried basis)
|
99.6%
|
Residual Solvents
Methanol
Dichloromethane
n-Hexane
Ethyl acetate
Tetrahydrofuran
|
≤ 3000ppm
≤ 600ppm
≤ 290ppm
≤ 5000ppm
≤ 720ppm
|
Not detected
Not detected
Not detected
800 ppm
Not detected
|
Conclusion
|
Complies with the in-house standards
|