Ranitidine Impurity 1

Development of a new methodology for the determination of N-nitrosamines impurities in ranitidine pharmaceuticals using microextraction and gas chromatography-mass spectrometry
Claudia Giménez-Campillo, Marta Pastor-Belda, Natalia Campillo, Manuel Hernández-Córdoba, PilarViñas
Talanta Volume 223, Part 2, 1 February 2021, 121659

Ranitidine Impurity 1 is chemically (Z)-N-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-1-(methylthio)-2-nitroethen-1-amine. Ranitidine Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Ranitidine Impurity 1 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 Ranitidine.

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.