item |
specification |
test result |
description |
white or off-white crystalline powder |
conform |
ir: |
match with the reference ir spectrum | conform |
retention time: |
should be similar to that of the reference solution |
conform |
assay |
97.5%~100.5% | 98.21% |
melting point: |
229℃~232℃,in-house |
230.0~231.0℃ |
specific rotation: |
+89° ~+93° |
+90.11° |
individual impurity: |
≤1.0% |
0.57% |
total impurities: |
≤2.0% |
1.98%
|
loss on drying: |
≤0.1%,in-house |
0.04%
|
sulfated ash: |
≤0.1%,in-house |
0.02% |
heavy metal: |
≤0.001%,in-house |
<0.001% |
arsenic: |
≤0.0003%,in-house | <0.0001% |