Montelukast Sodium EP Impurity B

Method development and validation for the simultaneous estimation of montelukast and acebrophylline in bulk and tablet dosage forms by RP-​HPLC
By Ankitha, M.; Ashitha, S.; Sri, Ragasudha A.; Latha, Madhavi P. V.; Devi, Uma P.
From Journal of Global Trends in Pharmaceutical Sciences (2021), 12(1), 9173-9179
 
Montelukast microsuspension with hypromellose for improved stability and oral absorption
By Lee, Ha Ryeong; Park, Hyun Jin; Park, Jun Soo; Park, Dong Woo; Ho, Myoung Jin; Kim, Dong Yoon; Lee, Hyo Chun; Kim, Eun Jeong; Song, Woo Heon; Park, Jun Sang; et al
From International Journal of Biological Macromolecules (2021), 183, 1732-1742
 
Analytical method development and validation for simultaneous estimation of Bilastine and Montelukast sodium by UV spectrophotometry
By Raj, R. Mohan; Sankar, A. S. K.; Vetrichelvan, T.
From World Journal of Pharmacy and Pharmaceutical Sciences (2021), 10(1), 680-687

Montelukast Sodium EP Impurity B is chemically [1-[[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-methylethenyl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetic acid Sodium salt (as per EP);[1-[[[(1R)-1-[3-[(E)-2-(7-Chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-methylethenyl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetic acid Sodium salt (as per USP). It is also known as Montelukast Methylstyrene (USP). Montelukast Sodium EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Montelukast Sodium EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Montelukast.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.