Uses: It is used to lower blood pressure and prevent chest pain

Specification: IP/BP/EP/USP

CAS No:      111470-99-6

Chemical Name: 2-[(2-Aminoethoxy)-Methyl]-4-(2-Chlorophenyl)-1,4-Dihydro-6-Methyl-3,5- Pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester Benzene Sulfonate

Product Specifications:

Appearance:- Almost white powder.

Solubility:- Slightly soluble in water freely soluble in methanol sparingly soluble in ethanol (95%)slightly soluble in 2-propanol

Idenfication:- HPLC , IR

Related substances:- by TLC  

• Total impurities:- NMT 0.30%
• Number of spots of >0.10%  and <0.30%:- NMT 2 spots

Sulphated Ash:- NMT 0.20%w/w

Water Content:- NMT 0.20%w/w

Assay:- 97.00% to 102.00% w/w on anhydrous basis

Residual solvents:-

• Methanol:- NMT 1000ppm
• Hexane:- NMT 290ppm
• Ethyl acetate:-NMT 1000ppm
• Toluene:-NMT 500ppm

Microbial analysis:-

• Total aerobic microbial:- NMT 1000cfu/g
• Total combined yeast and moulds count:- NMT 100cfu/g
• Pathogens:- Shall be absent per gram