Gamithromycin Impurity 1

Gamithromycin Impurity 1 is chemically (2R,3S,4R,5S,8R,10R,11R,12S,13S,14R)-11-(((2S,3S,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2-ethyl-3,4,10,13-tetrahydroxy-3,5,8,10,12,14-hexamethyl-1-oxa-7-azacyclopentadecan-15-one . Gamithromycin Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Gamithromycin 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 Gamithromycin Impurity 1.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. K.M.Pharma products are for analytical purpose only and not for human use.