Pharmaceutical Small Polar Molecules

Comprehensive analysis, including inorganics and chromatographically challenging compounds.

SIFT-MS represents a major breakthrough for the pharmaceutical industry due to its ability to comprehensively analyze diverse VOCs and inorganic gas impurities with very high sample throughput.  It quantifies VOCs directly in real-time to sub-part-per-billion (ppb) concentrations, so that product issues are detected earlier and resolved immediately, delivering economic benefits to all stakeholders.

Direct analysis using selected ion flow tube mass spectrometry (SIFT-MS) enables real-time monitoring of formaldehyde to sub-part-per-billion concentrations. SIFT-MS simplifies and accelerates both sampling and analysis of formaldehyde, providing 25-fold throughput enhancements.

This webinar describes SIFT-MS applications in the pharmaceutical industry, including:

• Its use as an alternative procedure for USP <467> residual solvent analysis
• Rapid, quantitative analysis of leachable formaldehyde from polyoxymethylene polymer and PEG excipient
• High-throughput headspace screening for nitrosamine residues in drug products
• Fast turnaround, simplified analysis of ethylene oxide residues in detergents used for cleaning validation.

This application note describes how challenging formaldehyde residue analysis becomes routine by utilizing automated thermal desorption-selected ion flow tube mass spectrometry (TD-SIFT-MS).

This application note demonstrates that by applying a strategy in accordance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Validation of Analytical Procedures: Text and Methodology Q2(R1) Guidelines (or “ICH Q2(R1)”) to direct analysis methods using SIFT-MS, successful validation is readily achieved – even for formaldehyde.

This webcast focuses on case studies that demonstrate simple analysis of chromatographically challenging compounds. Formaldehyde receives special attention, as it is important across a wide range of industries (from environmental to pharmaceutical testing).

Various exciting applications of SIFT-MS formaldehyde analysis will be presented, including candle flame analysis, material emissions and evaluation of materials that scavenge gaseous formaldehyde.

Process analysis using SIFT-MS enables the drying process to be monitored past the drying end-point measurable using conventional weighing methods. This delivers greater efficiencies for production, and lowers risk of thermally damaging sensitive APIs.

Learn about direct mass spectrometry by SIFT-MS which provides real-time, quantitative analysis of volatile compounds with trace-level sensitivity.  There are also no requirements of chromatography, pre-concentration, or sample prep!  SIFT-MS is easy to use and interpret data. 

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.

SIFT-MS greatly simplifies formaldehyde detection and quantitation through direct, instantaneous, and sensitive (sub-ppbV) sample ionization, yielding sample throughputs of up to 250+ samples/day.

Quantitative analysis of NDMA 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 app note introduces the next generation of SIFT-MS, Syft Tracer^TM, which launched at Pittcon 2023.  It revolutionizes volatile impurities analysis workflows through unparalleled speed, performance stability, and reproducibility.  Learn about how this innovation to real-time trace gas detection outpaces chromatography-based methods in the analysis of challenging analytes such as formaldehyde in a PEG excipient.

Join us for this webinar to learn about Syft Tracer, the latest advancement of real-time, trace gas analysis by SIFT-MS which launched at Pittcon 2023. Hear how the recent product innovations unlock analytical bottlenecks and enable faster decisions to be made in critical process steps.

This application note describes a scenario in which Syft Tracer^TM replaces five chromatography systems and still has significant available sample capacity. SIFT-MS provides rapid, chromatography-free analysis that revolutionizes multiple workflows.

SIFT-MS can analyze residual solvents and other volatile impurities in water-insoluble articles using a two-step process: dissolution in compatible solvent, then dilution in water. This application note describes a systematic evaluation of the compatibility of six organic solvents with headspace-SIFT-MS analysis following this two-step process.  Quantitative headspace analysis is achieved at 12 samples/hr, providing significant productivity improvements compared with chromatographic approaches.

This webinar demonstrates how the new, automated Syft Tracer^TM SIFT-MS platform provides a comprehensive solution to workflow challenges and can replace multiple chromatographic systems.  Learn about how combining SIFT-MS with automation provides a very flexible and high throughput solution for screening volatile impurities in pharmaceutical and consumer safety applications, revolutionizing workflows.

This E-book describes how next gen SIFT-MS enables rapid, continuous screening of toxic volatile impurities in pharmaceutical and consumer products. This advancement to SIFT-MS delivers trace-level detection sensitivity, unparalleled performance stability, superior selectivity, and highly reproducible, quantitative data. Never miss a contamination event again. 

This application note investigates concentration dependence of MHE calibration in sample matrix.  Across the full range of analytes investigated in this study, MHE calibration holds for at least one order of magnitude change in sample concentration.  For analytes in the C7–C9 range, the MHE calibration applies over two orders of magnitude analyte concentration. These results mean that the MHE workflow can be applied to a wider range of samples in the matrix, further reducing calibration demand.

This study evaluates a headspace-SIFT-MS approach for Polysorbate 80 products from multiple suppliers and evaluates ethylene oxide and acetaldehyde recoveries. Results confirm that the headspace-SIFT-MS procedure reliably quantifies these analytes without requiring purification of Polysorbate 80 for matrix-matching the calibration standard. Hence, headspace-SIFT-MS analysis of ethylene oxide and acetaldehyde can revolutionize existing workflows.

DMI is a very promising non-aqueous solvent because it can be used even without subsequent dilution in water.  Using a subset of residual solvents, this study confirms that moderately polar volatiles yield headspace responses that are independent of the volume of sample used. This means that cost and environmental impact can be reduced. Furthermore, with SIFT-MS this optimization can be carried out very rapidly due to direct sample analysis and high sample throughput.

Learn about the world's only 21 CFR Part 11 compliant real-time mass spec, Syft Tracer Pharm11, which is launching at Contract Pharma and debuting at AAPS 2023 PharmSci 360!

In this webinar, we introduce our new compliant real-time mass spectrometer solution, Syft Tracer Pharm11. A single instrument is capable of running up to 220 samples per day, and multiple methods and analyses can be performed in sequence. The direct headspace-SIFT-MS instrument is chromatography-free, and therefore the need for multiple columns and instrument downtime between methods does not exist.  We will highlight several common CDMO tests that have been performed and validated using headspace SIFT-MS, including residual solvents, ethylene oxide, nitrosamines and other extractables & leachables.

In this application note, enhanced MHE workflows are demonstrated using styrene, formaldehyde, and NDMA analyses in polystyrene polymer, Gelucire excipient, and ranitidine drug products, respectively. Reduced calibration frequency in routine analysis enables significant workflow benefits to be realized, including four-fold faster time to first result for quantitative analysis of condensed-phase samples.  Over 220 samples per day can be analyzed quantitatively for diverse volatile impurities using the enhanced MHE-SIFT-MS workflow.

Watch this on-demand webinar featuring Mark Perkins (Element), Professor Chris Price (CMAC, University of Strathclyde) and Aaron Smith (CMAC, University of Strathclyde) to learn how SIFT-MS provides real-time analysis of volatile impurities when determining solvent drying end points, volatile degradation products, or volatile impurities during hot melt extrusion.

SIFT-MS is a direct, real-time mass spectrometry (MS) technique which offers revolutionary volatile compound analysis capabilities to Pharma and CDMO labs due to its fast time to data, time efficient workflows, analytical flexibility, and ease of use. It expedites analytical workflows, such as residual solvents analysis, by generating faster results than traditional methods. Syft Tracer Pharm11 is a SIFT-MS-based solution that includes SyftAuditTracer software designed for 21 CFR Part 11 compliant environments. This app note describes how volatile impurities can be characterized in real-time including nitrosamines, ethylene oxide, and residual solvents.

This white paper describes how SyftAuditTracer software supports compliance with 21 CFR Part 11 regulations in pharma and CDMO environments.  SyftAuditTracer is part of the Syft Tracer Pharm11 bundle solution for high-throughput, compliant workflows.

This paper describes a proposed high-throughput method for analyzing nitrosamines in drug product using Headspace–SIFT-MS.  In this study, N-nitrosodimethylamine (NDMA) was quantified directly and rapidly from drug product without dissolution, at levels well below the regulatory acceptable intake of 96 ng day−1.  Use of the novel MHE-SIFT-MS approach may enable a wider screening of drug products to be conducted, since it provides around a three-fold increase in daily sample throughput.