Application Notes: General

This innovative AEX method replaces toxic TMAC with non-toxic choline-Cl, ensuring safety and efficiency in AAV capsid analysis, applicable across multiple AAV serotypes.

The use of method development software with analytical quality by design (AQbD) approaches can produce robust methods but are limited by both access to the software and user proficiency. Other approaches require more manual intervention to select the correct conditions, interpret the results, and make decisions based on the data. This application note, we explore using a systematic screening protocol to develop a method for the analysis of a mixture of nine structurally similar spice cannabinoids.

Advances in LC-MS/MS technology have allowed for a more comprehensive and rapid multi-class drug method to be developed. This highlighted method allows for the use of a protein precipitation and sample filtration with Thomson eXtreme|Filter Vials® followed by a rapid 8 min/sample run time, thus allowing for the reduction in multiple LC-MS/MS methods being run in the laboratory, freeing up valuable instrument time.

Triazine herbicides are commonly used in crop management to remove invasive plant species. These herbicides disrupt the photosynthesis cycle, leading to plant death and can contaminate soil and groundwater if used in high enough concentrations and for long enough duration. As such, the monitoring of these herbicides is important to minimize and monitor contamination. The app note outlines using a systematic screening protocol to develop a method for the analysis of a mixture of seven structurally similar triazine herbicides.

Often, method development activities are performed “on the fly” with tight timelines to achieve the goal of developing robust methods quickly. Unfortunately, the approach to method development is an often-overlooked aspect of the process. In this app note, we talk about employing a systematic screening protocol, which utilizes a structured decision-making process, alleviates the pressure on the analyst to select the best set of conditions, and streamlines the method development process.

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.