Nicergoline

ITEMS 

SPECIFICATION

RESULTS

Appearance 

White or buff powder  

White powder

Melting point 

133ºC--136ºC

135--136ºC

Specific optical rotation

Conforms 

Conform 

Clarity and color of the solution 

Clear 

Clear 

Related substances

Total impurity ≤1.5%

0.18%

Nor-nocergoline (B)≤0.50%

0.02%

Chioronicergoline (A)≤0.5%

0.04%

MeLUOL (C)≤0.30%

0.02%

Unidentified impurity:≤0.30%

0.06%

Water 

≤0.5%

0.06%

Heavy metal 

≤20ppm

Conform 

Residue on ignition 

≤0.05%

0.02%

Assay 

98.5%--102%

99.3%

Residue solvents

Conform 

Conform 

1

Acetone 

≤1000ppm

450ppm

2

Diethyl ether

≤2000ppm

140ppm

3

Ethanol 

≤1000ppm

40ppm

4

Methanol 

≤1000ppm

90ppm

5

Toluene 

≤500ppm

30ppm

6

Dichloromethan 

≤100ppm

<50ppm

7

Triethylamine 

≤500ppm

230ppm

Conclusion 

Conform with EP 5.0

Storage :In the shade of dark and situation. And low temperature(+2--+8ºC)