Abstract
This research articles focus on identification and characterisation of unknown impurity that is present in theRactopamine hydrochloride (RHCL) an Active drug substance(API). The various regulatory guidelines emphasise to identify the unknown impurities present in the drug substances and drug product and therefore it is very important to identify and characterise these impurities. The unknown impurity present in the drug substance was synthesized in the laboratory and it was further purified by the preparatory HPLC(PHPLC).The purified impurity taken for Characterisation by Mass spectrometry(MS),UV Profile,NMR.The investigational reports concludes that impurity present in the drug substance is Dimer of RHCL. The peaks of the dimers were well separated from the other known impurities. The extensive analytical investigations clearly indicates that the impurities with retention time of 1.2 and 1.24 isO-[β-Hydroxy- β-(4-hydroxyphenyl)ethyl] Ractopamine Analogue-1/Analogue-2 which is another dimer Impurity of the RHCL.This impurity is not reported in any monographs or by any drug manufacturers.
