|
TESTING ITEMS |
SPECIFICATION |
RESULTS |
|
Appearance |
A white or yellowish crystalline powder |
Complies |
|
Solubility |
Slightly solube in water, in acetone, in alcohol and in methylene, chloride |
Complies |
|
Identification |
c)Infrared a)Melting point 159~163℃ b)Specific absorbance 365~395 |
c)Complies a)160.0~160.3℃ b)376 |
|
Loss on drying |
≤0.5% |
0.21% |
|
Residue on ignition |
≤0.1% |
0.04% |
|
Heavy metals |
≤20ppm |
<20ppm |
|
Particle size |
40~60mesh |
Complies |
|
Residual solvents |
Ethanediol≤620ppm |
<620ppm |
|
Appearance of solution |
SuspensionⅡand solution GY6 |
Complies |
|
Related substances |
1)Impurity≤0.1% 2)Total impurity ≤0.2% 3)Disregard limited ≤0.01% |
0.047% 0.080% 0.01% |
|
Assay |
99.0%~ 101.0% |
99.53% |
|
Conclusion: The Product Conforms to BP/USP.
|
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