Patent ID: 7141602
Filing Date: 2006-11-28
Classification: A61K,B01D,C07C

Abstract:
1. A composition of a purified HMG-CoA reductase inhibitor having a purity of at least 99.7%, the composition consisting of pravastatin sodium salt and a total level of impurity of not more than 0.3%, wherein the total level of impurity includes a reduced level of at least one impurity selected from the group consisting of: (aR,bR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-hydroxy-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-hydroxy-1-naphtaleneheptanioic acid monosodium salt, (aR,bR.1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-((2S)-2-methyl-(3S)-3-hydroxy-1-oxobutoxy)-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-((2S)-2-methyl-(3R)-3-hydroxy-1-oxobutoxy)-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,6R)-1,2-dihydro-b,d,6-trihydroxy-2-methyl- 1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,6S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-((2S)-2-methyl-1-oxobutoxy)-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-((2S)-2-methyl-1-oxo-2-3-en-butoxy)-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,8 S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,3-trihydroxy-2-methyl-8-((2S)-2-methyl-1-oxobutoxy)-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-((2S)-2-methyl-1-oxopentoxy)-1-naphtaleneheptanioic acid monosodium salt, (aR,bR,1 S,2S,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d-dihydroxy-2-methyl-8-((2S)-2-methyl-3-hydroxy-1-oxobutoxy)-1-naphtaleneheptanioic acid monosodium salt, and (aR,bR,1S,2S,8S,8aR)-1,2,6,7,8,8a-hexahydro-b,d-dihydroxy-2-methyl-8-((2S)-2-methyl-4-hydroxy-1-oxobutoxy)-1-naphtalennheptanioic acid monosodium salt.