Quantitation of Genetox Impurities Using a Surrogate Standard Approach

Autor:	Heather Wang, Yuri Bereznitski, Roy Helmy, David J. Waterhouse, Regina Nardi
Rok vydání:	2013
Předmět:	Active ingredient Response factor Analyte Chromatography Impurity Chemistry Genotoxic impurities lipids (amino acids peptides and proteins) Mass spectrometry
Zdroj:	Journal of Analytical Sciences, Methods and Instrumentation. :167-172
ISSN:	2164-2753 2164-2745
DOI:	10.4236/jasmi.2013.33021
Popis:	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).
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::895a8a657af2cbfa1859c18109c195de https://doi.org/10.4236/jasmi.2013.33021 Zobrazit plný text záznamu