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.
European Pharmacopoeia Monograph: Tacrolimus** tacrolimus european pharmacopoeia monograph
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. According to the Ph