Rk Pharma Solutions LLC

Rk Pharma Inc.

Hemant Mande

Ravishanker Kovi

Jayaraman Rao Kannapan

Jayaraman Kannappan

Ananda Babu Thirunavakarasu

Rajesh A Patel

Ritesh H Panchal

Varun L Zambare

Dusanapudi Naga Venkata Raghavulu

Jayaraman Kannapan

The present application provides method for producing methylene blue that includes the steps of providing a reaction mixture having one or more methylene blue intermediates; precipitating metal from the reaction mixture; and producing therefrom crude methylene blue. The crude may further be purified, resulting in methylene compounds having low impurities, preferably having a purity greater than about 97%, having Azure B impurity no greater than 2.5%, and/or a total metal content no greater than 77 ppm. Formulations containing such compounds are also provided.

Process for the purification of methylene blue

The present application provides processes for the purification of ferric carboxymaltose, the process includes the steps of dissolving crude ferric carboxymaltose in a first solvent; charging the ferric carboxymaltose solution in a reaction vessel with a second solvent and precipitating therefrom a ferric carboxymaltose precipitate; and isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.

Purification process of ferric carboxymaltose

Novel polymorphs of rucaparib camsylate include Form alpha having XRPD peaks at diffraction angles (2&#x3b8;) of 6.14&#xb1;0.2, 12.41&#xb1;0.2, 15.34&#xb1;0.2, 15.95&#xb1;0.2, 16.36&#xb1;0.2, 16.51&#xb1;0.2 and 19.67&#xb1;0.2, Form beta having XRPD peaks at diffraction angles (2&#x3b8;) of 6.86&#xb1;0.2, 9.58&#xb1;0.2, 12.75&#xb1;0.2, 14.56&#xb1;0.2, 15.05&#xb1;0.2, 20.76&#xb1;0.2 and 22.45&#xb1;0.2, and Form gamma having XRPD peaks at diffraction angles (2&#x3b8;) of 9.5&#xb1;0.2, 12.73&#xb1;0.2, 14.77&#xb1;0.2, 15.16&#xb1;0.2, 20.62&#xb1;0.2, 22.33&#xb1;0.2, 22.63&#xb1;0.2 and 27.29&#xb1;0.2. Methods are disclosed for the preparation of such polymorphic forms and pharmaceutical compositions containing such polymorphic forms. A method is disclosed for preparing a highly pure Form B of rucaparib camsylate. Pharmaceutical compositions containing highly pure Form B prepared by the method are disclosed.

Polymorphs of rucaparib camsylate and methods of making same

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Gujarat, India

Hemant Mande