%0 Journal Article
%T Quantitation of Genetox Impurities Using a Surrogate Standard Approach
%A Heather Wang
%A Regina Nardi
%A Yuri Bereznitski
%A Roy Helmy
%A David J. Waterhouse
%J Journal of Analytical Sciences, Methods and Instrumentation
%P 167-172
%@ 2164-2753
%D 2013
%I Scientific Research Publishing
%R 10.4236/jasmi.2013.33021
%X <p class=\"MsoNormal\">
	<span lang=\"EN-US\">With the ever increasing complexity of
active pharmaceutical ingredient (API) preparations, more potential genotoxic
impurities (PGI¡¯s) are being observed. It is thus necessary to determine if
these PGI¡¯s are present in the final API¡¯s, and if they are present, to ensure
the levels are acceptable for any clinical uses. For PGI¡¯s that have authentic
standards available, quantitation can be accomplished in a straightforward
manner. However, for PGI¡¯s that are expected to form through rearrangements or
side reactions, authentic standards may not be readily available, significantly
complicating the analysis. In this study we describe a surrogate standard
approach for quantifying PGI¡¯s that allows for relative response factor
calculations of PGI species utilizing both gas chromatography-mass spectrometry
(GC-MS) and liquid chromatography-mass spectrometry (LC-MS).</span><span lang=\"EN-US\"><o:p></o:p></span> 
</p>
%K Potential Genotoxic Impurity (PGI)
%K Active Pharmaceutical Ingredient (API)
%K Mass Spectrometry
%K Surrogate Standard
%K Analyte
%K Relative Response Factor (RRF)
%U http://www.scirp.org/journal/PaperInformation.aspx?PaperID=37225