Process for manufacture of simvastatin
AssigneeLupin Limited
InventorsSubhash Rajaram Kadam, Mahendra Raghunath Patil, Madhukar Shaligram Patil, Sachin Arun Sasane
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Abstract
An improved method for manufacture of simvastatin of formula (I) in high purity. The process for preparation of compound (I) comprises the steps of agitating a compound of formula (II), wherein R is hydrogen, NH4+ or an alkali metal in an organic solvent and in an inert atmosphere at a temperature of between 27° C. to 40° C. in the presence of a weak acid followed by neutralization with an organic base and obtaining compound of formula (I) in high purity and substantially free of impurities through a step of isolation and crystallization.
Claims10
A process for preparation of compound (I)
- comprising agitating a compound of formula (II),
- wherein R is NH4+
- in dichloromethane, wherein the proportion of the solvent to substrate is between 17 and 20 times (w/w) per gram of compound (II), in an inert atmosphere at a temperature of between 27° C. to 40° C. in the presence of orthophosphoric acid, followed by neutralization with an inorganic base and obtaining compound of formula (I) in high purity and substantially free of impurities through isolation and crystallization.
Dependencies are inferred from the claim text.