Process for producing atorvastatin hemicalcium

Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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C514S423000, C548S537000, C548S561000, C548S562000, C548S563000

Reexamination Certificate

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07615647

ABSTRACT:
A process is provided for preparing pharmaceutical grade atorvastatin hemicalcium salt comprising:(a) deesterifying,wherein R is an ester protecting group to(b) extracting R(R*,R*)-3 into an organic solvent or mixture of solvents,(c) adding a base of formula NR1R2R3wherein R1, R2and R3are 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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John Landgrebe, Extraction and Drying, Chapter 6, Organic Laboratory, 4thedition, p. 123-132.
Baumann. Kelvin L et al.; The Convergent Synthesis of CI-981. an Optically Active, Highly Potent Tissue Selective Inhibitor of HMG-CoA Reductase; Tetrahedron Letters; vol. 33. No. 17, pp. 2283-2284, 1992; Pergamon Press Ltd., Great Britain.

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