Application Notes: General

Quantitative ethylene oxide analysis in Polysorbate 80 excipient is greatly simplified using SIFT-MS, with a time to first test result that is eight-fold faster than the current compendial method and a daily sample throughput that is 9- to 14-fold higher. In this application note, a simplified EtO method is presented that uses a much smaller quantity of PS80 for analysis than headspace GC-FID.

This application note describes head-to-head comparison of GC-FID and SIFT-MS analyses of Class 2A and 2B residual solvents. The techniques perform similarly for linearity and repeatability, but SIFT-MS provides superior performance for accuracy and recovery. Furthermore, SIFT-MS provides greater than 11-fold increase in sample throughput and significantly reduces the time taken to report quantitative results (over six times faster for a full calibration set).

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.

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.

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.

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

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

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.

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.