Tacrolimus Impurity 1

Tacrolimus Impurity 1 is chemically [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,25aR*]]- 3,4,5,6,8,11,12,13,14,15,16,17,18,19,23,24,25,25a-Octadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxypyrido[2,1-c][1,4]oxaazacyclodocosine-1,7,20(22H)-trione. Tacrolimus Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Tacrolimus 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 Tacrolimus.