文档介绍：Candesartan Cilexetil. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedure in the test anic Impurities is based on analyses performed using the Novopak brand of column containing 4-μm packing L1. The typical retention time for the candesartan cilexetil peak is about 13 min. (MD-CV: S. Ramakrishna.) RTS — C68161 Add the following: Candesartan Cilexetil 1H -Benzimidazole-7-carboxylic acid, 2-ethoxy-1-[[2 ?-(1 H -tetrazol-5-yl)[1,1 ?-biphenyl]-4-yl]methyl]-, 1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester, (± ); (± )-1-Hydroxyethyl 2-ethoxy-1-[ p -(o -1H -tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). [145040-37-5]. DEFINITION Candesartan Cilexetil contains NLT % and NMT % ofC 33H 34N 6O 6, calculated on anhydrous basis. IDENTIFICATION ? NFRARED A BSORPTION 197K : If the spectra obtained shows differences, proceed with the samples prepared as follows. Separately dissolve a quantity of USP Candesartan Cilexetil RS and Candesartan Cilexetil in alcohol. [ NOTE — Heating the solution may be necessary plete dissolution. ] Cool the solution in an ice bath, filter the crystals, and dry at 105 . ? B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution , as obtaine