pharmaceutical impurity analysis solutions - Lcms-connect.com

2ANALYTICAL TECHNOLOGIES FOR IMPURITY PROFILINGIN PHARMACEUTICAL DEVELOPMENTOverviewAn impurity profi le is a description of the identifi ed and unidentifi ed impurities presentin a new drug substance (Source: Guidance for Industry, Q3A Impurities in NewDrug Substances). Impurity profi ling processes usually begin with the detection ofimpurities, followed by their isolation and characterization. For all three types ofimpurities, it is critical to develop a robust method during process development thatcan eventually be validated and transferred to QA/QC. Developing reliable methodsfor impurities regulated at very low levels, such as genotoxic impurities, adds furtherchallenges to this process.To better detect, identify, quantify, and characterize the impurities present in drugsubstances and products, pharmaceutical scientists rely on fast analytical tools withhigh sensitivity and specifi city. Major analytical tools for impurity analysis includespectroscopy, chromatography, and various combinations of both, i.e. tandemtechniques. The appropriate technique is selected based on the nature of theimpurity and the level of information required from the analysis. There are variouscomplex analytical problems in pharmaceutical development that require the use ofmore than one analytical technique for their solution. Analytical techniques such asLC/UV, LC/MS, GC/MS, CE/MS, and LC/UV provide the orthogonal detection andcomplementary information that can address these challenges in a time effi cientmanner. As a result, they play a vital role in impurity profi ling of pharmaceuticals fromidentifi cation to the fi nal structure elucidation of unknown impurities.Table 2 summarizes of some of the techniques used in impurity analysis. Furtherdetails on key single and tandem techniques for impurity profi ling are foundin the section that follows.Table 2. Impurity analysis techniques.Type of ImpurityOrganic impuritiesInorganic/elemental impuritiesResidual solventsSee sections below for defi nitions of abbreviations.TechnologiesFTIR, Preparative LC, LC/UV, LC/MS (SQ, Q-TOF,and QQQ), CE, SFC, and NMRICP-OES and ICP-MSGC and GC/MS8