The Use of the ACQUITY QDa Detector for a Selective, Sensitive, and Robust Quantitative Method for a Potential Genotoxic Impurity

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Janet Hammond
Waters Corporation
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Genotoxic impurities (GTI) are compounds that have the potential to modify DNA and as a consequence cause cancer. It is important that drug manufacturers identify the presence of these impurities early in the drug development process, and develop analytical methods that are sensitive and specific enough to determine the levels in both drug substance and drug product.

Here, we describe an analytical method for the detection and quantitation of a GTI, 1-phenylpiperazine in an active pharmaceutical ingredient (API)at a limit of quantitation (LOQ) of 0.5 ppm relative to the API. It uses the ACQUITY QDa Detector, which is a small, simple to use robust mass detector and the ACQUITY UPLC H-Class System fitted with an ACQUITY UPLC Column Manager.

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