|
Tests
|
Standards
|
Results
|
| Appearance
|
A white crystalline powder
|
A white crystalline powder
|
|
Identification
|
Positive |
Positive
|
|
Melting range
|
168~172℃ |
169.2~170.2℃
|
|
Related substance
|
ImpurityJ not more than 10ppm
|
＜10ppm
|
|
ImpurityK not more than 50ppm
|
＜50ppm
|
|
ImpurityF not more than 0.05%
|
＜0.05%
|
|
Any other impurity not more than 0.05%
|
＜0.05%
|
|
Tatal of other impurity not more than 0.1%
|
＜0.1%
|
|
Heavy metals
|
Not more than20ppm
|
＜10ppm
|
|
Loss on drying
|
Not more than0.5%
|
0.3%
|
|
Sulphated ash
|
Not more than0.1%
|
0.07%
|
|
Assay
|
99.0~101.0%
|
99.4%
|
| Conclusion： Complies with EP4
|
