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AssigneeCadila Healthcare Limited
InventorsKumar Kamlesh SINGH, Sanjay Jagdish DESAI, Piyush Rajendra SHARMA, Daya Ram PAL, Sanjeev Kumar TRIPATHI, Mayur Ramnikbhai PATEL
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The present invention relates to a composition comprising high purity pyrrole derivative and method for preparation thereof. The present invention particularly relates to compositions comprising Saroglitazar magnesium having purity of 99.0% or more, and one or more of an aldehyde compound of Formula (II), diketo oxirane compound of Formula (III), hydroxy methyl compound of Formula (IV) or dimer compound of Formula (V), relative to saroglitazar magnesium, each present in an amount of about 0.15% or less, respectively, by weight, when measured by area percentage of HPLC.
A composition comprising substantially pure saroglitazar magnesium.
A compound selected from an aldehyde compound of Formula (II), a diketo oxirane compound of Formula (III), and a hydroxymethyl compound of Formula (IV),
A process for the preparation of the substantially pure saroglitazar magnesium, wherein the process comprises:
A stable composition comprising Saroglitazar magnesium, wherein the Saroglitazar magnesium having a purity of about 99.0% or more, by weight, by area percentage of HPLC, and one or more of the aldehyde compound of Formula (II), the diketo oxirane compound of Formula (III), the hydroxy methyl compound of Formula (IV), and the dimer compound of Formula (V), each present in an amount of about 0.15%, or less, by weight, relative to saroglitazar magnesium, for at least 6 months at 40° C.±2° C. temperature and 75%±5% relative humidity or at 25° C.±2° C. temperature and 60±5% relative humidity.
A pharmaceutical composition comprising substantially pure Saroglitazar magnesium together with a pharmaceutically acceptable excipients, diluents and carrier.
Dependencies are inferred from the claim text.