According to the Ph. Eur. monograph, tacrolimus is defined as a mixture of several macrolide lactones, with the main component being (3S,4R,5S,8E,9S,10R,11S,12S,15S)-5,9,11,15-tetrahydroxy-3,7,12,16-tetramethyl-2-(1E,3E,5E,7E,9E,11E,13E,15E)-1,17-dihydroxy-4,6,8,10,14-pentaoxoheptadeca-1,3,5,7,9,11,13,15-octaen-2-ylmethyl-2-(2R)-2,6-dideoxy-3-O-methyl-α-D-ribo-hexopyranosyloxy]-3-(1R)-1-hydroxyethyl]oxolane-2-one.

The Ph. Eur. monograph for tacrolimus is subject to periodic review and update. Future revisions to

The European Pharmacopoeia is a publication that sets standards for the quality of medicines in Europe. The Ph. Eur. monograph for tacrolimus provides a detailed description of the substance, its manufacture, and its quality control. The monograph is designed to ensure that tacrolimus products available in Europe meet the required standards of quality, purity, and potency.

European Pharmacopoeia Monograph: Tacrolimus**