Process for the purification of pravastatin
AssigneeSankyo Company, Limited
InventorsNobunari Sugio, Yasuyuki Takamatsu, Shunshi Kojima, Mutsuo Suzuki, Minoru Hagisawa, Kiyoshi Hamano
Life of this patent
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Abstract
A method of isolating or purifying pravastatin or its pharmaceutically acceptable salt characterized by involving, in the process of isolating or purifying pravastatin or its pharmacologically acceptable salt, the step of extracting pravastatin using an organic solvent represented by the formula CH3CO2R wherein R represents an alkyl group having 3 or more carbon atoms or the step of decomposing impurities using an inorganic acid or an inorganic base; and compositions containing pravastatin sodium thus obtained.
Claims35
A process for the isolation or purification of pravastatin or a pharmacologically acceptable salt thereof which process comprises culturing microorganisms to produce pravastatin, removing mycelium to leave a culture filtrate and extracting pravastatin and analogue thereof with an organic solvent, the improvement wherein the organic solvent is a solvent having the formula CH3CO2R wherein R represents an alkyl group having 3 to 6 carbon atoms.
A process for the isolation or purification of pravastatin or a pharmacologically acceptable salt thereof obtained by culturing microorganisms which process comprises decomposing impurities using an inorganic acid.
A process for the isolation or purification of pravastatin or a pharmacologically acceptable salt thereof obtained by culturing microorganisms which process comprises decomposing impurities with an inorganic base.
A process for the isolation or purification of pravastatin or a pharmacologically acceptable salt thereof obtained by culturing microorganisms which process comprises
- extraction of pravastatin and analogues thereof with an organic solvent having the formula CH3CO2R wherein R represents an alkyl group having 3 to 6 carbons and decomposing impurities using an inorganic acid.
A process for the isolation or purification of pravastatin or a pharmacologically acceptable salt thereof obtained by culturing microorganisms which process comprises
- extraction of pravastatin and analogues thereof with an organic solvent having the formula CH3CO2R wherein R represents an alkyl group having 3 to 6 carbons and
- decomposing impurities using an inorganic base.
A process for the isolation or purification of pravastatin or a pharmacologically acceptable salt thereof obtained by culturing microorganisms which process comprises decomposing impurities using an inorganic acid and decomposing impurities using an inorganic base.
A process for the isolation or purification of pravastatin or a pharmacologically acceptable salt thereof obtained by culturing microorganisms which process comprises extracting pravastatin and analogues thereof with an organic solvent having the formula CH3CO2R wherein R represents an alkyl group having 3 to 6 carbons decomposing impurities with an inorganic acid and decomposing impurities with an inorganic base.
A process for the isolation or purification of pravastatin sodium containing a compound of formula (I) as an impurity which process comprises removing a compound of formula (I) so that the quantity of the compound of formula (1) is reduced to 0.1% or less by weight of the quantity of pravastatin sodium by extracting pravastatin and analogues thereof with an organic solvent having the formula CH3CO2R wherein R represents an alkyl group having 3 to 6 carbons;
- and decomposing impurities using an inorganic acid:
- 12
A process for the isolation or purification of pravastatin sodium containing a compound of formula (I) as an impurity which process comprises removing a compound of formula (I) so that the quantity of the compound of formula (I) is reduced to 0.1% or less by weight of the quantity of pravastatin sodium by decomposing impurities with an inorganic acid and decomposing impurities with an inorganic base:
- 13
A process for the isolation or purification of pravastatin sodium containing a compound of formula (I) as an impurity which process comprises removing a compound of formula (I) so that the quantity of the compound of formula (I) is reduced to 0.1% or less by weight of the quantity of pravastatin sodium by extracting pravastatin and analogues thereof into an organic solvent having the formula CH3CO2R wherein R represents an alkyl group having 3 to 6 carbons;
- and decomposing impurities with an inorganic acid;
- and decomposing impurities with an inorganic base:
- 14
A process for the isolation or purification of pravastatin sodium containing a compound of formula (I) as an impurity which process comprises removing a compound of formula (I) so that the quantity of the compound of formula (1) is reduced to 0.1% or less by weight of the quantity of pravastatin sodium by extracting pravastatin and analogues thereof with an organic solvent having the formula CH3CO2R wherein R represents an alkyl group having 3 to 6 carbons;
- and decomposing impurities with an inorganic base:
- 15
A composition comprising pravastatin sodium which is industrially produced and contains a compound of formula (I) the quantity of which is 0.1% or less by weight of the quantity of pravastatin sodium.
- 16
A composition comprising pravastatin sodium according to claim 33 which is industrially produced and contains 99.5% or more of pravastatin sodium.
Dependencies are inferred from the claim text.