Cilnidipine for Clinical, Hospital

Chemical Name : 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-methoxyethyl (2E)-3-phenyl-2-propenyl ester.

Physical & Chemical Properties : Light Yellow crystalline powder, Practically insoluble in water, Sparingly soluble in ethanol

USE : Cilnidipine (INN) is a calcium channel blocker. Cilnidipine is the novel calcium antagonist accompanied with L-type and N-type calcium channel blocking function. It was jointly developed by Fuji Viscera Pharmaceutical Company, Japan and Ajinomoto, Japan and approved to come into market for the first time and used for high blood pressure treatment in 1995. Compared with other calcium antagonists. cilnidipine can act on the N-type calcium channel that existing sympathetic nerve end besides acting on L-type calcium channel that similar to most of the calcium antagonists. Cilnidipine is approved for use in Japan, China,India, Korea and some European countries.

Identification :

• By IR : The transmission minima (absorption maxima) in the spectrum obtained with the substance to be examined correspond in position and relative size to those in the spectrum obtained with the Cilnidipine working standard.
• By HPLC : The retention time of the major peak in the chromatogram of the sample preparation corresponds in that of the peak due to Cilnidipine in the chromatogram of the standard preparation, as obtained in Assay.

Related Substances (by HPLC) :

• Any Single Impurity - Not more than 0.5%
• Total Of Impurities - Not more than 1.0%

Residual solvent :

• Methanol - Not more than 3000 ppm
• Isopropyl Alcohol - Not more than 5000 ppm
• Toluene(NMT 890 ppm)

Particle Size :

• 90% Particles are less than 30 micrones
• 50% Particles are less than 20 micrones
• 10% Particles are less than 10 micrones.