Tacrolimus Hydroxy Acid Impurity

Tacrolimus Hydroxy Acid Impurity is chemically (3S,4R,5S,8R,12S,14S,15R,16S,18R,25aS,E)-8-Allyl-5,15,19-trihydroxy-3-((E)-1-((1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl)prop-1-en-2-yl)-14,16-dimethoxy-4,10,12,18-tetramethyl-1,7,20-trioxo-1,3,4,5,6,7,8,11,12,13,14,15,16,17,18,19,20,22,23,24,25,25a-docosahydropyrido[2,1-c][1]oxa[4]azacyclodocosine-19-carboxylic acid. Tacrolimus Hydroxy Acid Impurity is supplied with detailed characterization data compliant with regulatory guideline. Tacrolimus Hydroxy Acid Impurity 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 Tacrolimus.