ITEM |
STANDARD |
RESULTS |
Appearance |
white or almost white crystalline powder |
white crystalline powder |
Solubility |
Practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol |
Complies |
IR |
Complies |
Complies |
Melting point |
About 96℃ |
97.3℃~98.8℃ |
Appearance of solution |
The solution is clear and colorless |
Complies |
Related substances |
Total impurities |
≤0.70% |
<0.70% |
Impurity F |
≤0.50% |
0.12% |
Impurity B |
≤0.20% |
Absent |
Impurity A,D,E,G,H |
≤0.10% |
<0.10% |
Any other impurity |
≤0.10% |
<0.10% |
Ethanol |
≤5000ppm |
Absent |
Butyl acetate |
≤5000ppm |
400ppm |
Toluene |
≤890ppm |
Absent |
Sulphated ash |
≤0.10% |
0.04% |
Loss on drying |
≤0.50% |
0.02% |
Heavy Metal |
≤20ppm |
Complies |
Assay (on the dried basis) |
98%~102.0% |
99.70% |
Conclusion |
Meets the Requirements |