Introduction
Nicergoline is an ergot derivative used to treat senile dementia and other disorders with vascular origins.

Function
1. Nicergoline is a semi-synthetic ergotine derivative with alpha receptor blocking and vascularization effects.
2. It can enhance the metabolism of brain cell energy, increase the utilization of oxygen and glucose, promote the conversion of neurotransmitter dopamine and enhance nerve conduction, strengthen the biosynthesis of brain protein, and improve brain function.
3. Rapid absorption after oral administration, with absolute bioavailability less than 5%.
4. The pharmacokinetics of the product was not affected by age. About 80% of this product is excreted by kidneys.
5. In patients with severe renal insufficiency, the excretion of metabolites in urine is significantly reduced.

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)

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