Strategy for identification of leachables in packaged pharmaceutical liquid formulations

Journal of Pharmaceutical and Biomedical Analysis
Changkang PanRichard Vivilecchia

Abstract

Drug stability is one of the key properties to be monitored in pharmaceutical drug development. Drug degradation products, impurities and/or leachables from the drug product and packages may have significant impacts on drug efficacy, safety profile and storage conditions. In the registration stability samples of an ophthalmic pharmaceutical drug product, an unknown compound was found at a level of 0.19% by HPLC analysis. Subsequent liquid chromatography/mass spectrometry (LC/MS) analysis with electrospray ionization (ESI) indicated that the unknown was not related to the drug substance and was most likely a leachable. Identification of this unknown leachable was needed to evaluate the impact on drug safety. Through systematic extraction of various components or component combination of the packaging materials, and subsequently LC/MS analysis, the unknown was found to be a leachable coming from the varnish applied to the label. In general, using LC/MS alone is not sufficient to elucidate the structure of a complete unknown. Gas chromatography/mass spectrometry (GC/MS) was then conducted with a chemical ionization (CI) source to determine the retention time and mass of the compound of interest. Both CI and ESI sources generated t...Continue Reading

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Citations

Apr 1, 2011·Journal of Pharmaceutical Sciences·Changkang PanMichael Motto
Dec 30, 2009·Journal of Pharmaceutical Sciences·Aditya A WakankarSherry Martin-Moe
Dec 19, 2012·Journal of Pharmaceutical and Biomedical Analysis·Barbara L ArmstrongGyorgy Vas
Apr 24, 2012·Journal of Pharmaceutical and Biomedical Analysis·Saranjit SinghRavi P Shah
Dec 23, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·René Holm, David P Elder
Feb 26, 2013·Biotechnology Journal·Anne Luise TscheliessnigAlois Jungbauer
May 6, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Pauline MuratValérie Simon
Aug 5, 2009·Rapid Communications in Mass Spectrometry : RCM·Simone CristoniPietro Traldi
May 8, 2009·Analytical Chemistry·R K Gilpin, C S Gilpin

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