Real-Time Analysis of Volatile Pharmaceutical & Consumer Product Impurities and Bioreactor Headspace Compounds
Selected ion flow tube mass spectrometry (SIFT-MS) provides real-time, selective, and economic analysis of volatile impurities present in pharmaceutical and consumer products. Volatile compounds that are difficult to target with chromatographic methods are easily analyzed by SIFT-MS including residual solvents, nitrosamines, ethylene oxide and formaldehyde. It is also an effective way to monitor environmental conditions in real-time such as changes in bioreactor headspace compounds during fermentation. Because SIFT-MS does not require chromatographic separation, the same instrument configuration can be used to analyze many different compounds back-to-back without the need for changeover routines. Read more about how SIFT-MS simplifies volatile analysis.
Revolutionary Productivity for Volatile Residue and Impurity Analysis
This application note describes a scenario in which Syft Tracer analyzed the same number of samples in 9 hours that took 5 chromatographic systems 24 hours to complete and still had capacity to spare. Next gen SIFT-MS provides rapid, chromatography-free workflows which revolutionize volatile compound analysis.
DownloadAnalysis of N-Nitrosodimethylamine (NDMA) Impurity in Rantidine Products Using SIFT-MS
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.
DownloadSimple Rapid Analysis of Ethylene Oxide in a Polysorbate 80 Excipient Using SIFT-MS
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.
DownloadHead-to-Head Comparison of Class 2A and 2B Residual Solvents Analysis Using SIFT-MS and 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).
DownloadSimple Rapid Analysis of Formaldehyde Impurities in Gelucire
This application note describes how SIFT-MS greatly simplifies formaldehyde detection and quantitation through direct, instantaneous, and sensitive (sub-ppbV) sample ionization. Sample throughputs of up to 250+ samples/day are possible using the method detailed in this study.
DownloadReal-Time Monitoring of Bioreactor Production Processes Using SIFT-MS
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.
DownloadSimple Rapid Analysis of Packaging for Volatile MOSH and MOAH Contaminants
This application note demonstrates that automated headspace-SIFT-MS analysis has the potential to screen larger sample numbers for the volatile MOH fraction, providing a rapid indication of packaging material contamination. As benzene has also recently been found to be problematic in commercial products, Headspace-SIFT-MS can screen over 220 samples per day for volatile MOSH and MOAH compounds – nearly seven-fold more samples than the routine liquid and gas chromatography method.
DownloadHigh-Throughput Quantitative Analysis of Benzene in Personal Care Products Using Headspace-SIFT-MS
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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