Rabeprazole EP Impurity I

Identification, isolation and characterization of new impurity in rabeprazole sodium
P. SreenivasaRao, Uttam KumarRay, P. BadarinadhGupta, D.V.N. SrinivasaRao, AminulIslam, PradeepRajput, K.Mukkanti
Journal of Pharmaceutical and Biomedical Analysis Volume 52, Issue 4, 1 August 2010, Pages 620-624
 
Development and validation of a stability indicating hplc method for the estimation of rabeprazole impurities in pharmaceutical dosage forms by design of experiments
T.v. raghava raju, s.raja kumar1, i.mrutyunjaya rao, n.someswara rao
Asian J Pharm Clin Res, Vol 6, Suppl4, 2013, 43-51
 
Identification and characterization of stressed degradation products of rabeprazole using LC-ESI/MS/MS and 1H-NMR experiments: in vitro toxicity evaluation of major degradation products
Murali Mohan Bhandi,a   Roshan M. Borkar,a   G. Shankar,a   Snehal Raut,b   Narayana Nageshc  and  R. Srinivas*
RSC Adv., 2016,6, 10719-10735
 
A Validated RP-HPLC Method for Simultaneous Quantification of Three Potential Genotoxic N-Oxides in Key Intermediate of Rabeprazole sodium
Karri Visweswara Rao1,2* , K Padmaja Reddy1 , Y Ravindra kumar1 , N Rajan
Journal of Pharmacy Research 2012,5(11),5206-5209

Rabeprazole EP Impurity I is chemically 2-[(1H-1,3-Benzimidazole-2-sulfonyl)methyl]-4-(3-methoxypropoxy)-3-methylpyridine 1-oxide (as per EP). It is also known as Rabeprazole Sulfone N-Oxide. Rabeprazole EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Rabeprazole EP Impurity I 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 Rabeprazole.

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.