发明名称 |
A PROCESS FOR PREPARING PAROXETINE HCl WHICH LIMITS FORMATION OF PINK COLORED COMPOUNDS. |
摘要 |
<p>The present invention provides a process for preparing paroxetine HCl from paroxetine base which provides paroxetine HCl substantially free of pink-colored compounds or an impurity identified by an HPLC RRT of about 1.5. The processes of the present invention utilize a buffer, a molar ratio of HCl to paroxetine base of less than one, and crystallize/recrystallize in the presence of an effective amount of an anti-oxidant. A preferred way to create a buffer is by using ammonium chloride. A preferred anti-oxidant is ascorbic acid. The present invention also provides for re-crystallizing paroxetine HCl prepared by the above methods or any other methods in the presence of an effective amount of an anti-oxidant such as ascorbic acid. A preferred solvent system for recrystallization is a mixture of acetone and methanol. Processes of the present invention can combine these various features.</p> |
申请公布号 |
MXPA03011594(A) |
申请公布日期 |
2005.09.08 |
申请号 |
MX2003PA11594 |
申请日期 |
2002.06.14 |
申请人 |
TEVA PHARMACEUTICAL INDUSTRIES LTD. |
发明人 |
GIDEON PILARSKI |
分类号 |
A61K31/443;A61K31/445;A61P25/00;A61P25/16;A61P25/18;A61P25/22;A61P25/24;A61P43/00;C07D;C07D405/12 |
主分类号 |
A61K31/443 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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