Process for producing atorvastatin hemicalcium

Details Process for producing atorvastatin hemicalcium Process for producing atorvastatin hemicalcium

C - Chemistry, Metallurgy

07

D

C07D 405/06 (2006.01) A61P 9/10 (2006.01) C07D 207/34 (2006.01)

Patent

CA 2499047

A process is provided for preparing pharmaceutical grade atorvastatin hemicalcium salt comprising: (a) deesterifying, Image wherein R is an ester protecting group to Image (b) extracting R(R*,R*)-3 into an organic solvent or mixture of solvents, (c) adding a base of formula NR1R2R3 wherein R1, R2 and R3 are independently selected from H, substituted or non-substituted C1 to C7 alkyl, C6 to C9 aryl, C8 to C10 aralkyl or aminoalkyl to form atorvastatin base salt, (d) isolating by precipitation of the above atorvastatin base salt and purifying when necessary, (e) converting atorvastatin base salt to atorvastatin hemicalcium salt by treatment with a calcium salt solution, and (f) isolating the atorvastatin hemicalcium salt.

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