Losartan EP Impurity M

Development and validation of a stability-indicating HPLC method for the simultaneous determination of Losartan potassium, hydrochlorothiazide, and their degradation products
Deanne L. Hertzog a,*, Jennifer Finnegan McCafferty b , Xueguang Fang b , R. Jeffrey Tyrrell c , Robert A. Reed
Journal of Pharmaceutical and Biomedical Analysis 30 (2002) 747–760
 
An Efficient, Commercially Viable, and Safe Process for Preparation of Losartan Potassium, an Angiotensin II Receptor Antagonist
Suri Babu Madasu,†,‡ N. A. Vekariya,*,† Ch Koteswaramma,† Aminul Islam,† Paul Douglas Sanasi,‡ and Raghu Babu Korupolu
Org. Process Res. Dev. 2012, 16, 12, 2025–2030

Losartan EP Impurity M is chemically [2-Butyl-1-[[2′-[2-[[2-butyl-4-chloro-1-[[2′-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol-5-yl]methyl]-2H-tetrazol-5-yl]biphenyl-4-yl]methyl]-4-chloro-1H-imidazol-5-yl]methanol (as per EP). It is also known as Losartan USP Related Compound E ; Losartan N2-Dimer ; N2-Losartanyl Losartan ; Losartan Potassium 2-H Dimer. Losartan EP Impurity M is supplied with detailed characterization data compliant with regulatory guideline. Losartan EP Impurity M 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 Losartan.

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.