Tacrolimus EP Impurity D

Development and validation of a stability indicating HPLC assay method for tacrolimus in semi-​solid dosage form & bulk drug
By Gejage, Santosh; Amin, Purnima
From Indo American Journal of Pharmaceutical Research (2018), 8(5), 1097-1106

Tacrolimus EP Impurity D is chemically (3S,4R,5S,8S,9E,12S,14S,15R,16S,18R,19R,26aS)-5,19-Dihydroxy-3-[(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(prop-2-en-1-yl)-3,4,5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-octadecahydro-7H-15,19-epoxypyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(23H)-tetrone (as per EP); (3S,4R,5S,8S,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone (as per USP) . It is also known as Tacrolimum 8-Epimer (USP) ; 8-epi-Tacrolimus. Tacrolimus EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Tacrolimus EP Impurity D 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.

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.