The present invention relates to a process for preparation of Dimethyl fumarate of formula I comprises reaction of Fumaric acid with methanol in the presence of phosphorous acid or phosphoric acid. Formula I

The specification provides a process for the preparation of Mirabegron and intermediates or salt thereof. The present invention also provides a solid form of Mirabegron intermediates, ((R)-2-[[2-(4-aminophenyl)ethyl]amino]-1-phenylethanol and (R)-N-(4-aminophenethyl)-2-hydroxy-2-phenylacetamide or salt thereof, havi...

The specification discloses a crystalline Alpha-1 form of Mirabegron has purity of more than or equal to 99 % when measured by HPLC. In the further aspect of specification describes a process for the preparation of a crystalline Alpha-1 form of Mirabegron, which holds the moisture more than 0.2% over the entire rang...

A process of preparing a stable pharmaceutical composition comprising amorphous of Mirabegron comprising the steps of: Dissolving Mirabegron in a solvent(s); Stirring the mixture until the Mirabegron get completely dissolved or dispersed; Evaporating the solution by spraying on the drymix bed consisting of polyme...

The specification discloses a solid form of (R)-N-(4-aminophenethyl)-2-hydroxy-2-phenylacetamide or salt thereof has purity more than or equal to 99 % when measured by HPLC and its process for the preparation.

The present invention relates to simple, sensitive, accurate, precise and reproducible method for quantification of Prasugrel base from the formulation containing Prasugrel hydrochloride by a continuous HPLC process involving removal of the salt and elution of the base during the process.