Active Pharmaceutical Ingredients

Nimodipine:

Chemical Names: Nimodipine; 66085-59-4; Nimotop; Periplum; Nimodipino; Nimodipinum

Molecular Formula: C₂₁H₂₆N₂O₇

Molecular Weight: 418.44034 g/mol

CAS No: 66085-59-4

USE : Nimodipine is a calcium channel blockader with preferential cerebrovascular activity. It has marked cerebrovascular dilating effects and lowers blood pressure.

01. Appearance : Light yellow or yellow, crystalline powder.

02. Solubility : Practically insoluble in water, freely soluble in ethyl acetate, sparingly soluble in anhydrous ethanol.

03. Identification :
a) Optical rotation : -0.10° to + 0.10°
b) By Infrared Absorption Spectrophotometry : The IR spectrum of the sample should be concordant with the spectrum of Nimodipine reference standard.

04. Appearance of solution : Solution S is clear.

05. Optical Rotation : -0.10° to + 0.10°

06. Related Substance by HPLC :
a) Impurity-C : NMT 0.2 %
b) Unspecified Impurity (Each impurity) : NMT 0.1 %
c) Total Impurities : NMT 0.5 %.

07. Loss on drying (at 105⁰ c) : Not More Than 0.5 %.

08. Residue On Ignition : Not more than 0.1 % W/W

09. Sulfated ash : Not more than 0.1 %.

10. Assay By Titrimetry (on dried basis) : 98.5 % to 101.5 %

11. Additional Test : Melting Point : 120⁰ C to 125⁰ C

12. Assay By HPLC (on dried basis) : 98.5 % to 101.5 %.

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

Molecular Formula : C₂₇H₂₈N₂O₇

Molecular Weight : 492.54

C.A.S No. : 132203-70-4

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.

1.0. Appearance : Light yellow crystalline powder.

2.0. Solubility : Practically insoluble in water, Sparingly soluble in ethanol

3.0. Identification :
a) 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.
b) 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.

4.0. Melting Point : 105⁰C to 110⁰C

5.0. Related Substances (by HPLC) : a) Any Single Impurity : Not more than 0.5%
b) Total Of Impurities : Not more than 1.0%

6.0. Heavy Metals : Not more than 10 ppm

7.0. Loss on drying : Not more than 0.5 %

8.0. Ignited residue (Sulphated Ash): Not more than 0.1 % w/w

9.0. Assay ( On Dried Basis) : Not less than 99.0% and not more than 102.0%.

10.0. Residual solvent :
a) Methanol : Not more than 3000 ppm
b) Isopropyl Alcohol : Not more than 5000 ppm
c) Toluene(NMT 890 ppm)

11.0. Particle Size :
a) 90% Particles are less than 30 micrones
b) 50% Particles are less than 20 micrones
c) 10% Particles are less than 10 micrones.