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918972-54-0

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Identification, synthesis and characterization of impurities of Montelukast sodium
Montelukast sodium is a selective leukotriene receptor antagonist which inhibits cysteinyl leukotriene CysLT1 receptor. Various synthesis of Montelukast is published. During laboratory optimization and later in bulk synthesis formation of various impurities was detected. Besides, pharma Europa draft mention nine process related impurities. However, the method of preparation of most of these impurities is not available in literature. Also, different route of synthesis will have different impurity profile and those process related impurities are not covered in pharmacopeias. In this study we report the synthesis of possible process impurities, including seven impurities (A-H) mentioned in pharma Europa.
Sunil Kumar,Anjaneyulu,Hima Bindu
p. 4536 - 4546
(2012/02/04)

SPECIFIC IMPURITIES OF MONTELUKAST
The subject-matter of the invention consists in a method of removing specific impurities of montelukast of formula (I), which occur due to chemical instability of the target substance and also contaminate the substance in the preparation process. Further, methods of isolation of specific impurities of montelukast defined by formulae (V-A), (IV-A), (XIIIa-A), (XIIIb-A) and analytic methods used for the control of the production of montelukast in the pharmaceutical quality.
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Page/Page column 24-25

(2009/10/22)

PROCESS FOR PREPARING MONTELUKAST SODIUM CONTAINING CONTROLLED LEVELS OF IMPURITIES
The present invention is directed to a process of preparing montelukast or a salt thereof with minimal amounts of impurities, such as a dehydration impurity (compound (VI)) or a cyclic ether impurity (compound (VIII)).
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Page/Page column 9

(2008/12/07)

PROCESS FOR PREPARING MONTELUKAST SODIUM CONTAINING CONTROLLED LEVELS OF IMPURITIES
The present invention is directed to a process of preparing montelukast or a salt thereof with minimal amounts of impurities, such as a dehydration impurity (compound (VI)) or a cyclic ether impurity (compound (VIII)).
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Page/Page column 21

(2008/12/07)

PREPARATION OF MONTELUKAST
A process for preparing amorphous montelukast sodium comprises removing solvent from a solution comprising montelukast sodium using agitated thin film drying.
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Page/Page column 26

(2008/06/13)

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Chemical Properties

Melting Point: 154-156°C
Boiling Point: 729.2±60.0 °C(Predicted)
Density: 1.238±0.06 g/cm3(Predicted)
Solubility:Chloroform (Slightly), DMSO (Slightly)
Storage Temp.:-20°C Freezer, Under Inert Atmosphere
Vapor Pressure: 0mmHg at 25°C
PKA: 4.76±0.10(Predicted)
PSA: 75.49000
LogP: 9.75370

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