Mebeverine EP Impurity J

Stress degradation studies on mebeverine hydrochloride and development of a validated stability indicating uplc method
V. Srinivasan,1,3 H. Sivaramakrishnan,2 B. Karthikeyan,3 T. S. Balaji,1 and S. Vijayabaskar
Journal of Liquid Chromatography & Related Technologies, 34:1631–1644, 2011
 
Development and validation of stability indicating HPLC and HPTLC methods for determination of sulpiride and mebeverine hydrochloride in combination
Ibrahim A. Naguib a,*, Mohammed Abdelkawy
European Journal of Medicinal Chemistry 45 (2010) 3719-3725
 
Improved partial least squares models for stability-indicating analysis of mebeverine and sulpiride mixtures in pharmaceutical preparation: A comparative study
Hany W. Darwisha∗ and Ibrahim A. Naguib
Drug Test Anal. 2013 May;5(5):325-33.
 
Simultaneous determination of sulpiride and mebeverine by HPLC method using fluorescence detection: application to real human plasma
Mohamed I Walash, Mohie M Kh Sharaf El-din, Nahed M El-enany, Manal I Eid & Shereen M Shalan
Chemistry Central Journal 2012, 6:13

Mebeverine EP Impurity J is chemically Mixture of N-ethyl-4-[4-[ethyl[(2RS)-1-(4-methoxyphenyl)propan-2-yl]amino]butoxy]-N-[(2R)-1-(4-methoxyphenyl)propan-2-yl]butan-1-amine and N-ethyl-4-[4-[ethyl[(2RS)-1-(4-methoxyphenyl)propan-2-yl]amino]butoxy]-N-[(2S)-1-(4-methoxyphenyl)propan-2-yl]butan-1-amine (as per EP). Mebeverine EP Impurity J is supplied with detailed characterization data compliant with regulatory guideline. Mebeverine EP Impurity J 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 Mebeverine.

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.