The development of an efficient mass balance approach for the purity assignment of organic calibration standards

Analytical and Bioanalytical Chemistry
Stephen R DaviesGreg J Tarrant

Abstract

The purity determination of organic calibration standards using the traditional mass balance approach is described. Demonstrated examples highlight the potential for bias in each measurement and the need to implement an approach that provides a cross-check for each result, affording fit for purpose purity values in a timely and cost-effective manner. Chromatographic techniques such as gas chromatography with flame ionisation detection (GC-FID) and high-performance liquid chromatography with UV detection (HPLC-UV), combined with mass and NMR spectroscopy, provide a detailed impurity profile allowing an efficient conversion of chromatographic peak areas into relative mass fractions, generally avoiding the need to calibrate each impurity present. For samples analysed by GC-FID, a conservative measurement uncertainty budget is described, including a component to cover potential variations in the response of each unidentified impurity. An alternative approach is also detailed in which extensive purification eliminates the detector response factor issue, facilitating the certification of a super-pure calibration standard which can be used to quantify the main component in less-pure candidate materials. This latter approach is particu...Continue Reading

References

Jul 14, 2001·Fresenius' Journal of Analytical Chemistry·B King, S Westwood
May 17, 2005·Journal of Pharmaceutical and Biomedical Analysis·F Malz, H Jancke
Apr 17, 2008·Analytical and Bioanalytical Chemistry·T Le Goff, S Wood
Aug 7, 2012·Chemical & Pharmaceutical Bulletin·Atul AwasthiSanjay Garg
Feb 14, 2013·Analytical Chemistry·Steven WestwoodRobert Ian Wielgosz
Jun 21, 2014·Analytical and Bioanalytical Chemistry·Stephen R DaviesJames M Hook

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Citations

Aug 22, 2018·Drug Testing and Analysis·Stephen R DaviesRima Chakrabarty

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