Abstract: PROCESS FOR PREPARATION OF BENZYL ESTER MALEATE SALT OF QUINAPRIL 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).
FORM-2
THE PATENTS ACT, 1970 (39 OF 1970)
COMPLETE SPECIFICATION
(See Section 10; rule 13)
1. TITLE OF INVENTION
A NOVEL PROCESS FOR PREPARATION OF MALEIC
ACID SALT OF QUINAPRIL BENZYAL ESTER
LUPIN LIMITED
159, CST Road, Kalina,
Santa Cruz (East)
Mumbai - 400 098
Maharashtra, India
An Indian Company
The following specification particularly describes the nature of the invention and the manner in which it is to be performed.
| # | Name | Date |
|---|---|---|
| 1 | 1320-mum-2004-form 3(09-12-2004).pdf | 2004-12-09 |
| 1 | 213399- FORM 27- 2012.pdf | 2024-03-11 |
| 2 | 1320-MUM-2004-ABSTRACT(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 2 | 1320-mum-2004-power of attorney(10-12-2004).pdf | 2004-12-10 |
| 3 | 1320-mum-2004-form pct-isa-210(10-12-2004).pdf | 2004-12-10 |
| 3 | 1320-MUM-2004-CLAIMS(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 4 | 1320-mum-2004-form pct-ipea-409(10-12-2004).pdf | 2004-12-10 |
| 4 | 1320-MUM-2004-CORRESPONDENCE(IPO)-(4-2-2008).pdf | 2018-08-09 |
| 5 | 1320-MUM-2004-FORM 3(10-12-2004).pdf | 2004-12-10 |
| 5 | 1320-MUM-2004-CORRESPONDENCE(RENEWAL PAYMENT LETTER)-(7-12-2011).pdf | 2018-08-09 |
| 6 | 1320-MUM-2004-FORM 2(TITLE PAGE)-(10-12-2004).pdf | 2004-12-10 |
| 6 | 1320-mum-2004-correspondence-ipo-(21-1-2007).pdf | 2018-08-09 |
| 7 | 1320-mum-2004-form 2(granted)-(10-12-2004).pdf | 2004-12-10 |
| 7 | 1320-MUM-2004-DESCRIPTION(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 8 | 1320-MUM-2004-FORM 2(COMPLETE)-(10-12-2004).pdf | 2004-12-10 |
| 8 | 1320-MUM-2004-DRAWING(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 9 | 1320-mum-2004-form 1(10-12-2004).pdf | 2004-12-10 |
| 9 | 1320-MUM-2004-FORM 1(31-2-2005).pdf | 2018-08-09 |
| 10 | 1320-mum-2004-drawing(10-12-2004).pdf | 2004-12-10 |
| 10 | 1320-MUM-2004-FORM 2(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 11 | 1320-MUM-2004-DESCRIPTION(COMPLETE)-(10-12-2004).pdf | 2004-12-10 |
| 11 | 1320-MUM-2004-FORM 2(TITLE PAGE)-(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 12 | 1320-mum-2004-claims(granted)-(10-12-2004).pdf | 2004-12-10 |
| 12 | abstract1.jpg | 2018-08-09 |
| 13 | 1320-MUM-2004-CLAIMS(10-12-2004).pdf | 2004-12-10 |
| 13 | 1320-MUM-2004-CORRESPONDENCE-(18-11-2013).pdf | 2013-11-18 |
| 14 | 1320-mum-2004-abstract(10-12-2004).pdf | 2004-12-10 |
| 14 | 1320-MUM-2004-CORRESPONDENCE(RENEWAL PAYMENT LETTER)-(26-11-2012).pdf | 2012-11-26 |
| 15 | 1320-MUM-2004-CORRESPONDENCE(RENEWAL PAYMENT LETTER)-(12-11-2008).pdf | 2008-11-12 |
| 16 | 1320-mum-2004-correspondence(31-10-2007).pdf | 2007-10-31 |
| 17 | 1320-mum-2004-form 18(24-02-2005).pdf | 2005-02-24 |
| 18 | 1320-mum-2004-form 18(24-02-2005).pdf | 2005-02-24 |
| 19 | 1320-mum-2004-correspondence(31-10-2007).pdf | 2007-10-31 |
| 20 | 1320-MUM-2004-CORRESPONDENCE(RENEWAL PAYMENT LETTER)-(12-11-2008).pdf | 2008-11-12 |
| 21 | 1320-mum-2004-abstract(10-12-2004).pdf | 2004-12-10 |
| 21 | 1320-MUM-2004-CORRESPONDENCE(RENEWAL PAYMENT LETTER)-(26-11-2012).pdf | 2012-11-26 |
| 22 | 1320-MUM-2004-CLAIMS(10-12-2004).pdf | 2004-12-10 |
| 22 | 1320-MUM-2004-CORRESPONDENCE-(18-11-2013).pdf | 2013-11-18 |
| 23 | 1320-mum-2004-claims(granted)-(10-12-2004).pdf | 2004-12-10 |
| 23 | abstract1.jpg | 2018-08-09 |
| 24 | 1320-MUM-2004-DESCRIPTION(COMPLETE)-(10-12-2004).pdf | 2004-12-10 |
| 24 | 1320-MUM-2004-FORM 2(TITLE PAGE)-(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 25 | 1320-mum-2004-drawing(10-12-2004).pdf | 2004-12-10 |
| 25 | 1320-MUM-2004-FORM 2(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 26 | 1320-MUM-2004-FORM 1(31-2-2005).pdf | 2018-08-09 |
| 26 | 1320-mum-2004-form 1(10-12-2004).pdf | 2004-12-10 |
| 27 | 1320-MUM-2004-FORM 2(COMPLETE)-(10-12-2004).pdf | 2004-12-10 |
| 27 | 1320-MUM-2004-DRAWING(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 28 | 1320-mum-2004-form 2(granted)-(10-12-2004).pdf | 2004-12-10 |
| 28 | 1320-MUM-2004-DESCRIPTION(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 29 | 1320-MUM-2004-FORM 2(TITLE PAGE)-(10-12-2004).pdf | 2004-12-10 |
| 29 | 1320-mum-2004-correspondence-ipo-(21-1-2007).pdf | 2018-08-09 |
| 30 | 1320-MUM-2004-FORM 3(10-12-2004).pdf | 2004-12-10 |
| 30 | 1320-MUM-2004-CORRESPONDENCE(RENEWAL PAYMENT LETTER)-(7-12-2011).pdf | 2018-08-09 |
| 31 | 1320-mum-2004-form pct-ipea-409(10-12-2004).pdf | 2004-12-10 |
| 31 | 1320-MUM-2004-CORRESPONDENCE(IPO)-(4-2-2008).pdf | 2018-08-09 |
| 32 | 1320-mum-2004-form pct-isa-210(10-12-2004).pdf | 2004-12-10 |
| 32 | 1320-MUM-2004-CLAIMS(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 33 | 1320-MUM-2004-ABSTRACT(GRANTED)-(1-1-2008).pdf | 2018-08-09 |
| 33 | 1320-mum-2004-power of attorney(10-12-2004).pdf | 2004-12-10 |
| 34 | 1320-mum-2004-form 3(09-12-2004).pdf | 2004-12-09 |
| 34 | 213399- FORM 27- 2012.pdf | 2024-03-11 |