Title of Invention

PROCESS OF PREPARATION OF QUINAPRIL HYDROCHLORIDE

Abstract

A process for preparation of a novel crystalline form of quinapril hydrochloride of formula(I). A process for preparation of amorphous form of quinapril hydrochloride, of high purity and conforming to pharmacopoeial specifications, by the use of the novel crystalline quinapril hydrochloride as an intermediate. The said process involves adjusting the pH of a solution of the benzyl ester maleate salt of quinapril of formula(V) between 7.5-8.5 in a mixture of water and an organic solvent to obtain free base compound of formula(V); subjecting the free base of compound (V) thus obtained to catalytic hydrogenation in an alcoholic solvent in the presence of concentrated hydrochloric acid or hydrogen chloride dissolved in an alcoholic solvent and in the presence of catalytic amounts of Pd/C to obtain a residue containing formula(I); crystallization of the said residue by evaporating the alcoholic solvent from a nitrolkane solvent to give crystalline quinapril hydrochloride, associated with a solvent of the nitroalkane solvent, and drying the crystalline quinapril hydrochloride nitroalkane solvate at a temperature between 40 and 45 degree/C under vacuum to give pure quinapril hydrochloride of formula(I).

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Documents:

1114-MUM-2002-ABSTRACT(13-12-2002).pdf

1114-MUM-2002-ABSTRACT(GRANTED)-(1-1-2008).pdf

1114-MUM-2002-ANNEXURE TO FORM 3(15-4-2004).pdf

1114-MUM-2002-CANCELLED PAGES(3-12-2004).pdf

1114-MUM-2002-CLAIMS(13-12-2002).pdf

1114-MUM-2002-CLAIMS(AMENDED)-(3-12-2004).pdf

1114-mum-2002-claims(granted) (04-06-2003).pdf

1114-mum-2002-claims(granted)-(04-06-2003).doc

1114-MUM-2002-CLAIMS(GRANTED)-(1-1-2008).pdf

1114-mum-2002-correspondence(15-09-2006).pdf

1114-mum-2002-correspondence(ipo)-(16-08-2004).pdf

1114-MUM-2002-CORRESPONDENCE(IPO)-(23-1-2008).pdf

1114-MUM-2002-DESCRIPTION(COMPLETE)-(13-12-2002).pdf

1114-MUM-2002-DESCRIPTION(GRANTED)-(1-1-2008).pdf

1114-MUM-2002-DRAWING(13-12-2002).pdf

1114-MUM-2002-DRAWING(AMENDED)-(27-1-2003).pdf

1114-MUM-2002-DRAWING(GRANTED)-(1-1-2008).pdf

1114-mum-2002-drawing-(13-01-2002).pdf

1114-mum-2002-form 1(13-12-2002).pdf

1114-mum-2002-form 1(27-01-2003).pdf

1114-mum-2002-form 19(06-08-2003).pdf

1114-mum-2002-form 19(11-08-2003).pdf

1114-MUM-2002-FORM 19(11-8-2003).pdf

1114-MUM-2002-FORM 2(COMPLETE)-(13-12-2002).pdf

1114-MUM-2002-FORM 2(GRANTED)-(1-1-2008).pdf

1114-mum-2002-form 2(granted)-(13-01-2002).doc

1114-mum-2002-form 2(granted)-(13-01-2002).pdf

1114-MUM-2002-FORM 2(TITLE PAGE)-(13-12-2002).pdf

1114-MUM-2002-FORM 2(TITLE PAGE)-(GRANTED)-(1-1-2008).pdf

1114-mum-2002-form 3(12-12-2002).pdf

1114-MUM-2002-FORM 3(13-12-2002).pdf

1114-mum-2002-form-pct-isa-210-(04-06-2003).pdf

1114-MUM-2002-GENERAL POWER OF ATTORNEY(3-12-2004).pdf

1114-mum-2002-power of attorney(04-06-2003).pdf

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