Almotriptan EP Impurity B (Malate salt)

A validated reversed phase HPLC method for the determination of process-related impurities in almotriptan malate API
A. Phani Kumar a, V.R.L. Ganesh a, D.V. Subba Rao a, C. Anil a, B. Venugopala Rao a, V.S. Hariharakrishnan a,∗, A. Suneetha b, B. Syama Sundar c
Journal of Pharmaceutical and Biomedical Analysis 46 (2008) 792–798
 
Stability-Indicating Reversed-Phase UHPLC Method Development and Characterization of Degradation Products of Almotriptan Maleate by LC-QTOF-MS/MS
B Saibaba, Ch Vishnuvardhan, P Johnsi Rani, N Satheesh Kumar
Journal of Chromatographic Science, Volume 56, Issue 1, January 2018, Pages 6–17

Almotriptan EP Impurity B (Malate salt) is chemically 2-[2-[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]-5-[(pyrrolidine-1-sulfonyl)methyl]-1H-indol-3-yl]-N,N-dimethylethan-1-amine malate (1:1) (As per EP) ; 2-{1-({3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl}methyl)-5-[(pyrrolidin-1-ylsulfonyl)methyl]-1H-indol-3-yl}-N,N-dimethylethan-1-amine malate (1:1) (as per USP). It is also known as Almotriptan N-Dimer (USP). Almotriptan EP Impurity B (Malate salt) is supplied with detailed characterization data compliant with regulatory guideline. Almotriptan EP Impurity B (Malate salt) 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 Almotriptan.

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.