Special Issues-07-01-2020

Extractable and leachable (E&L) testing for finished pharmaceutical products, bioprocess manufacturing systems, and medical devices is currently a subject of intense interest. The majority of the challenges encountered in analytical workflows are related to the highly complex matrices and relatively low analyte evaluation thresholds seen in E&L studies. This paper provide options for executing E&L testing to supporting regulatory submissions. There are multiple compliant routes possible, and the presented workflows and analytical solutions are only one of multiple successful approaches.

Food contamination from mineral oil saturated hydrocarbons (MOSHs) and mineral oil aromatic hydrocarbons (MOAHs) is problematic and requires a sensitive analytical technique. These contaminants were analyzed using GC×GC with flame ionization detection (FID) and time-of-flight–MS (TOF–MS) parallel dual detection. The method provides enhanced chromatographic separation, along with the full mass spectra information, and overcomes difficult interferences, resulting in reduction of false positives over conventional GC–MS methods.

A novel liquid chromatography–tandem mass spectrometry (LC–MS/MS) method with a dual electrospray ionization (ESI) and atmospheric-pressure chemical ionization (APCI) source was developed for analysis of 66 pesticides and 5 mycotoxins regulated by the State of California in medium-chain triglyceride (MCT) oil cannabis tinctures. The limits of quantitation (LOQs) of all of the pesticides and mycotoxins were well below California state action limits of these analytes in cannabis-based non-inhalable or edible products. A total of 62 (out of 66) pesticides and 5 mycotoxins were analyzed using LC–MS/MS with an ESI source, and the remaining 4 pesticides were determined using LC–MS/MS with an APCI source. A simple, fast, and cheap acetonitrile solvent extraction method was used for sample preparation to get good recovery and achieve high throughput for this analysis. For late-eluted analytes, a number of internal standards were used to compensate for ion suppression effects from the hydrophobic matrix.

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