Arch Pharmalabs Limited

Orochem Technologies, Inc.

Ganesh Gurpur Pai

K Nanda Kishore

Narendra P Chaudhari

N Anjaneyulu

B N Ghogare

Asha Anil Oroskar

Rakesh Vikraman Nair Rema

Arun Kanti Mandal

Kamlesh Jayantilal Ranbhan

Abhilesh Agarwal

Kishore Nanda

A Anjaneyulu

N P Chaudhari

This invention concerns generally with a process for purifying crude pharmaceutical compositions, wherein the crude pharmaceutical composition comprises a sodium salt of Montelukast and more particularly relates to a process for the production of pharmaceutically pure preparations of Montelukast sodium using simulated moving bed technology, without requiring an intermediate acid formation step to separate isomers and to remove impurities.

Purification of montelukast using simulated moving bed

A method for the preparation of 4-fluoro-&#x3b1;-[2-methyl-1-oxopropyl]-&#x3b3;-oxo-N-&#x3b2;-diphenylbenzenebutanamide also known as 2-[2-(4-fluorophenyl)-2-oxo-1-phenylethyl]-4-methyl-3-oxo-pentanoic acid phenylamide of the formula I containing about 0.1% or less of &#x3b1;-[2-methyl-1-oxopropyl]-&#x3b3;-oxo-N-&#x3b2;-diphenylbenzene butanamide, about 0.05% or less of difluoro-&#x3b1;-[2-methyl-1-oxopropyl]-&#x3b3;-oxo-N-&#x3b2;-diphenylbenzene butanamide and about 0.1% or less of 3-[2-(4-Fluorophenyl)-2-oxo-1-phenyl-ethoxy]-4-methyl-pent-2-enoic acid phenylamide.

Method for the preparation of 4-fluoro-&#x3b1;-[2-methyl-1-oxopropyl]-&#x3b3;-oxo-N-&#x3b2;-diphenylbenzenebutanamide and products therefrom

A method for the preparation of 4-fluoro-&#x3b1;-[2-methyl-1-oxopropyl]-&#x3b3;-oxo-N-&#x3b2;-diphenylbenzenebutanamide also known as 2-[2-(4-fluorophenyl)-2-oxo-1-phenylethyl]-4-methyl-3-oxo-pentanoic acid phenylamide of the formula I containing about 0.1% or less of &#x3b1;-[2-methyl-1-oxopropyl]-&#x3b3;-oxo-N-p-diphenylbenzene butanamide, about 0.05% or less of difluoro-&#x3b1;-[2-methyl-1-oxopropyl]-&#x3b3;-oxo-N-&#x3b2;-diphenylbenzene butanamide and about 0.1% or less of 3-[2-(4-Fluorophenyl)-2-oxo-1-phenyl-ethoxy]-4-methyl-pent-2-enoic acid phenylamide.

Method for the preparation of 4-fluoro-&#x3b1;-[2-methyl-1-oxopropyl]-y-oxo-n-&#x3b2;-diphenylbenzenebutanamide and products therefrom

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Thane, India

Ganesh Gurpur Pai