Application Notes: General

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Quantitative analysis of volatile nitrosamine impurities in drug products is greatly simplified using SIFT-MS and has a three-fold throughput advantage (excluding sample prep benefits) over chromatographic methods. This application note describes the headspace-SIFT-MS analysis of ranitidine products which achieves a limit of quantitation of 2 ng g-1 for NDMA in 500 mg of drug product.

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The ability of SIFT-MS to monitor critical volatile organic compounds (VOCs) produced by a bioreactor in real-time at low parts-per-billion by volume (ppbV) concentrations is demonstrated. This application note presents the results of a pilot-scale feasibility study conducted over several weeks, demonstrating the utility of SIFT-MS for maximizing production outcomes.

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This application note demonstrates the speed of headspace-SIFT-MS methods for the analysis of benzene in personal care products (PCPs). In less than three hours, seven-point calibration curves can be generated and accurate quantification of benzene in PCPs achieved. SIFT-MS provides rapid, sensitive, and robust analysis of benzene and other contaminants in a variety of commercial products. Integration with a headspace autosampler enables rapid screening of hundreds of samples per day.

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This application news presents instrument operating conditions and instrument method performance statistics, including method linearity, accuracy, and precision, for priority pollutant pesticides and PCB congeners. The method validated in this application acted as guidance in developing ASTM D8543 Test Method for Determination of OCPs and PCBs in Aqueous Solution by a GC/MS/MS which is intended for proposal to EPA as an alternative test procedure (ATP) for EPA 608.3

EPA Method 1621 for AOF

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PFAS concerns demand sensitive testing. EPA Method 1621 screens for adsorbable organic fluorine (AOF). The Profiler-F Analyzer boasts sensitivity, recovery & precision.

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In this app note you will learn how to develop a highly specific, sensitive, and reproducible method for the quantitation of N-nitroso dabigatran etexilate impurity in dabigatran etexilate mesylate drug substance using an Agilent 6495C triple quadrupole LC/MS (LC/TQ) coupled to an Agilent 1290 Infinity II LC.

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Earlier assessment of molecules provides valuable insights into the manufacturing developability of molecules, reducing the need for unnecessary experimentation. The Intabio ZT system has the potential to make in-depth characterization of biopharmaceutical product charge variants quicker and more efficient to meet demanding timelines during early-phase clinical development.

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The U.S. Food and Drug Administration and the EPA advised pregnant women and those who might become pregnant to avoid certain fish known to be high in mercury. This study will investigate trace element concentrations including heavy metal concentrations in different types of fish and fish oil supplements available from local markets in New Jersey.

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In this podcast, we will look at different sources of potential heavy metal exposure and their concentrations in a variety of food products including fish, and beverages. In addition to the original research presented, we will compare other historical studies and public health findings to showcase the sources and concentrations of various heavy metals found in the food and water supply in order to build a more complete picture of heavy metal exposure through food and beverages.

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In this study, dried fruit samples (organic and regular raisins, sultanas and currants) and bread spreads (from different nuts and seeds; i.e. peanuts, almonds, sunflower etc.) were purchased from stores in the US, UK and Germany. Samples were digested using microwave digestion and tested by ICP-MS to determine heavy metal contamination and potential exposure.

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Spices and hot sauces were purchased at dollar stores, farmer’s markets, chain stores, and online. Samples included ‘organic’ products. Cryogenic grinding and microwave digestion were employed in sample processing prior to ICP-MS analysis to determine the presence and level of heavy metal contamination and adulteration.

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Professor Wan-Tang (Grace) Chen of the University of Massachusetts Lowell accepted our invite to participate in a virtual Q&A session. Dr. Chen directs the Plastics & Environment Research Laboratory at the university and was gracious enough to share what her team is working on, and how they’re leveraging the Pyrolysis-GC/MS technique in novel microplastics research.

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This application note demonstrates the applicability of the Biozen dSEC-2 column in understanding the biophysical integrity monoclonal antibodies and related proteins. The hydrophilic nature of the Biozen dSEC-2 stationary phase shows favorable aggregate profiles for forced degradation work under high salt conditions which is a known challenge when working with more hydrophobic hybrid particles for these studies.