Process for producing atorvastatin hemicalcium
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United States of America Patent
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Nov 10, 2009
Grant Date -
Sep 7, 2006
app pub date -
Aug 5, 2005
filing date -
Mar 1, 2005
priority date (Note) -
Expired
status (Latency Note)
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Abstract
A process is provided for preparing pharmaceutical grade atorvastatin hemicalcium salt comprising: (a) deesterifying, ##STR00001## wherein R is an ester protecting group to ##STR00002## (b) extracting R(R*,R*)-3 into an organic solvent or mixture of solvents, (c) adding a base of formula NR.sub.1R.sub.2R.sub.3 wherein R.sub.1, R.sub.2 and R.sub.3 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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