Items

Specification(BP2000)

Results

appearance

White or slightly yellow, crystalline powder

White crystalline

Solubility

Practically insoluble in water, soluble in methylene chloride, slightly soluble in anhydrousethanol

confirms

Identification (IR)

same wave numbers as that of the Vinpocetine, CRS similarly prepared

CRS similarly prepared.

Conforms

Specific Optical Rotation(On dried basis)

Between +127° and +134°

+132.7°

Related Substances (External Standard method)

Ethyl vincaminate(A)        

≤0.6%

Conforms

Apovincamine(B)     

≤0.5%

Conforms

Methoxyvinpocetine(C)

≤0.3%

Not detected

Dihydrovinpocetine(D)

≤ 0.5%

Not detected

Other single impurity

≤0.10%

Conforms

Total impurity

≤ 1.0%

0.19%

Loss on drying

≤ 0.5%

0.04%

Sulphated ash

≤ 0.1%

0.07%

Assay(On dried basis)

 98.5% ~101,5%   ,

100.2%

Conclusion

qualified