Volatile residue analysis in Drug Delivery Devices
SIFT-MS provides a very rapid and highly sensitive solution for the detection of residual monomers and other impurities in diverse drug delivery devices, including orally inhaled and nasal drug products (OINDPs), and parenteral and ophthalmic drug products (PODPs).
- Very high throughput screening via the elimination of chromatographic separation, delivering greatly reduced cost of analysis
- High selectivity and comprehensive analysis provided by eight rapidly switchable reagent ions
- High sensitivity, providing rapid warning of quality issues
- Wide linear and dynamic ranges enable one instrument to be applied readily to multiple analytical tasks
Analysis of multiple residual monomers in different polymer products.
Drug Delivery Devices benefits
Comprehensive analysis, including inorganics and chromatographically challenging compounds
Flexible sample delivery options, including automation and area sampling
Intuitive software and fast method development
High sensitivity and wide linearity range
Automated high-throughput headspace analysis
Drug Delivery Devices resources
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.
Formaldehyde in Air (sample bags)
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.
Rapid, Simplified Residual Solvent and Volatile Impurity Analysis Using SIFT-MS
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.
Pharma Method Validation - Formaldehyde
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.
Direct MS Simplifies Analysis of Challenging Compounds
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).
Residual Monomer Analysis
In this paper, the unique capabilities of SIFT-MS are illustrated for residual monomer analysis, using formaldehyde emissions from polyoxymethylene (POM) polymer to illustrate. SIFT-MS provides significant throughput increases for both testing laboratories and quality assurance/quality control (QA/QC) in a process environment.
Routine Analysis 3: SIFT-MS Method Development and Validation
In this webinar, we discuss how analytical method validation is approached for SIFT-MS so that data collected can be used to support regulatory requirements. This is achieved by applying a strategic approach in accordance with ICH Q2(R1) guidelines. Finally, we will illustrate SIFT-MS method validation using two case studies: 1) common toxic volatiles in water, 2) BTEX in soil following methanolic extraction.
Analysis of Volatile Emissions from Polymers and Paperboard
This webinar describes a recent addition to the portfolio of techniques available for routine sample analysis: SIFT-MS. SIFT-MS enables rapid, quantitative analysis of VOCs across the full spectrum of packaging materials. Detailed case studies will describe applications in polymeric and paperboard emissions analysis.
Drying Endpoint Monitoring Using SIFT-MS For Enhanced Manufacturing Of Active Pharmaceutical Ingredients
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.
SIFT-MS Selected Ion Flow Tube Mass Spectrometry
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.
Simple, 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.
Volatile Compound Analysis: Automated SIFT-MS
SIFT-MS provides direct, rapid sample analysis of volatile organic compounds (VOCs) with no or minimal sample prep required. When coupled with autosampler technology, SIFT-MS yields very high sample throughput (in excess of 100 samples per hour), including for challenging compounds like ammonia, formaldehyde and hydrogen sulfide. Learn how this direct mass spec technology serves a range of industries, from environmental analysis to food testing to pharma.
The SIFT-MS Automation Series: Episode 6 SIFT-MS Automation Past, Present and Future
In this sixth and final episode, Dr Perkins reflects on the automation journey and shares his practical "hot tips" for a wide variety of automated analyses. The webinar (and series!) concludes with a discussion of how automated SIFT-MS is an excellent complementary technique to the conventional laboratory "workhorse" techniques: gas and liquid chromatography.
The SIFT-MS Automation Series: Episode 5 Continuous Headspace Analysis… and Beyond and R&D laboratories.
In this fifth episode, Dr Perkins describes the novel continuous headspace analysis (CHA) technique that he developed to measure stripping of volatiles. (Note: CHA is not to be confused with dynamic headspace analysis!). In addition, Mark describes simple, very high-throughput gas sample bag analysis and touches on other recent developments – including thermal desorption-SIFT-MS.
The SIFT-MS Automation Series, Episode 3: Advanced Headspace Methods with SIFT-MS
In this third episode, Dr Perkins describes the application of SIFT-MS to multiple headspace extraction (MHE). You will learn how to determine matrix-independent concentrations from MHE. Furthermore, Dr Perkins describes how the speed of SIFT-MS analysis can be leveraged to accelerate method development for both SIFT-MS and conventional methods – for example, through rapid determination of headspace equilibration times.
The SIFT-MS Automation Series, Episode 2: Accelerate Static Headspace Analysis with SIFT-MS
In this second episode, Dr Perkins provides a practical guide to automated static headspace (SH) analysis with SIFT-MS. You will learn how SH-SIFT-MS can address throughput challenges and simplify analysis of chromatographically challenging species.
The SIFT-MS Automation Series, Episode 1: Why Automate Analysis?
In this first episode, Dr Perkins answers the important question:
Why Automate Analysis?
This webinar introduces the benefits of automation and discusses how they can be applied to SIFT-MS, enabling straightforward adoption by the contract laboratory.
SIFT-MS Method Validation Webinar
Mark describes how the ICH Q 2 (R1) guidelines can be readily applied to SIFT-MS methods, whether in scenarios where only the analytical technique is changed or for tasks that pose a unique analytical challenge. He presents case studies for two such scenarios: 1) methanolic extraction of BTEX compounds (benzene, toluene, ethylbenzene plus xylenes) from soil, 2) direct analysis of formaldehyde leaching into single-use pharmaceutical devices from polymeric components.
Simple, Rapid Analysis Of Formaldehyde Impurities In Gelucire Excipient Using SIFT-MS
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.
Feedback from a CDMO SIFT-MS User
Hear what Christopher Williams, Director of Development Services, Alcami Corporation, had to say about his experience using SIFT-MS.
Rapid Screening of Paperboard For Volatile Leachables Using Static Headspace-SIFT-MS
Automated SIFT-MS analysis rapidly screens paperboard packaging for a wide range of functional groups in a single analysis, assuring that the volatile emissions meet manufacturer specifications. This application note describes a Headspace-SIFT-MS method with throughput >10X faster than traditional GC/MS methods.
Rapid, Quantitative Analysis of Volatile Aldehyde Impurities In Paperboard Using Multiple Headspace Extraction
Quantitative determination of volatile aldehyde residues in paperboard is readily achieved using multiple headspace extraction-SIFT-MS analysis, with an eight-fold throughput increase over the equivalent conventional analysis.
Rapid Odor Screening of Paperboard Using Static Headspace-SIFT-MS
Automated SIFT-MS analysis coupled with multivariate statistical analysis provides rapid sensory screening of paperboard packaging, overcoming the low sample throughput of sensory panels. The ability to use HS-SIFT-MS to achieve throughput of 12 samples per hour is demonstrated.
Rapid, Simplified Residual Solvent and Volatile Impurity Analysis Using SIFT-MS
SIFT-MS provides real-time, selective, and economic analysis of challenging volatile compounds, such as residual solvents, formaldehyde, dimethylamine, and NDMA without requiring derivatization or other special handling.
High-Throughput Analysis of Volatile Impurities in Sustainable Packaging using SIFT-MS
Pharmaceutical and food products are susceptible to contamination from packaging, whether from polymeric materials, printing inks, or paperboard. SIFT-MS, a high-sensitivity direct-injection mass spectrometry technique, enables risks associated with sustainable packaging alternatives to be mitigated through economical, high-throughput automated analysis (typically a 4- to 15-fold increase over GC-MS).
High-Throughput Quantitative Analysis of Residual Monomer by Using MHE-SIFT-MS to Calibrate Single Headspace Injections
MHE-SIFT-MS provides rapid, matrix-independent, quantitative determination of volatile leachables in polymers and calibrates quantitative analysis based on single headspace injections. This approach enables over 200 samples per day to be analyzed, delivering rapid and economic analysis of volatile leachables such as residual monomers.
Syft Tracer: The Next Generation of Volatile Impurities Analysis for Enhanced Workflows
This app note introduces the next generation of SIFT-MS, Syft TracerTM, 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.
Head 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).
Recent developments and applications of selected ion flow tube mass spectrometry (SIFT‐MS)
SIFT‐MS is now recognized as the most versatile analytical technique for the identification and quantification of trace gases down to the parts‐per‐trillion by volume, pptv, range. This statement is supported by the wide reach of its applications, from real‐time analysis, obviating sample collection of very humid exhaled breath, to its adoption in industrial scenarios for air quality monitoring. This review touches on the recent extensions to the underpinning ion chemistry kinetics library and the alternative challenge of using nitrogen carrier gas instead of helium.
The Latest Innovation of Real-Time, High-Throughput Volatile Impurities Analysis by SIFT-MS
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.
Even Faster Quantitation Of Formaldehyde In Gelucire Excipient
This application note describes how the efficiency of a MHE workflow can be significantly improved for MHE-SIFT-MS due to the stability of the technique. Formaldehyde impurity is analyzed easily and quantitatively in Gelucire excipient with this improved approach. The time-to-result is reduced to 85 minutes for this system – six-fold faster than the conventional MHE-SIFT-MS approach. Quantitative analysis is achieved at the throughput of 220 samples/day.
Revolutionary Productivity For Volatile Residue and Impurity Analysis
This application note describes a scenario in which Syft TracerTM replaces five chromatography systems and still has significant available sample capacity. SIFT-MS provides rapid, chromatography-free analysis that revolutionizes multiple workflows.
Application Brief: Revolutionary Workflows for Volatile Impurities Analysis
This application brief summarizes a scenario relevant to contract research organization (CRO) and contract drug manufacturing organization (CDMO) laboratories where multiple volatile impurity methods need to be conducted in short runs. Five analyses are considered that can be handled by one Syft Tracer but require multiple legacy, chromatography instruments. For these analyses, SIFT-MS reports the first quantitative results 2- to 12-fold faster, and has sample throughputs 3- to 17-fold higher than the conventional procedures.
Headspace-SIFT-MS: Flexibility that Revolutionizes Workflows for Diverse Samples
The characteristic flexibility, stability, high throughput, and fast time to data of the Syft Tracer next-gen SIFT-MS instrument apply across multiple headspace approaches for diverse matrices. This application note briefly summarizes the use of (1) dissolution, (2) multiple headspace extraction (MHE), and (3) the method of standard additions, then provides a guide for identifying the appropriate headspace approach for various matrices.
Revolutionizing Workflows for Residual Solvents and Volatile Impurities Analyses by SIFT-MS
This webinar demonstrates how the new, automated Syft TracerTM 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.
Rapid Sensory Analysis of Paper Packaging Using SIFT-MS
This application note demonstrates that SIFT-MS effectively classifies paper samples by odor intensity rating and odor descriptor, in addition to distinguishing paper composition and mill of origin. When integrated with autosamplers, SIFT-MS provides throughputs of over 220 samples per day, supporting significantly enhanced quality assurance compared to conventional human sensory panels and gas chromatography-based analyses.
Pharmaceutical Residual Solvent Analysis: A Comparison of GC-FID and SIFT-MS Performance
This study expands upon the previous work by conducting a head-to-head comparison of GC-flame ionization detection (GC-FID) and SIFT-MS procedures. SIFT-MS analyzed samples over 11-fold faster than GC-FID, increasing daily sample throughput and reducing the time taken to determine the result. The results suggests that residual solvent analysis using SIFT-MS may support workflow improvements for pharmaceutical manufacturers.
Revolutionizing Volatile Impurities Analysis Through Next Gen SIFT-MS
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.
Improved MHE-SIFT-MS Workflows - Concentration Independent MHE Calibration
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.
Real-Time Analysis of Volatile Emissions from Hot-Melt Extrusion using Untargeted SIFT-MS
SIFT-MS provides unique capabilities that enable formulators to optimize the hot melt extrusion processes by minimizing polymer, API, and other excipient degradation. SIFT-MS provides real-time feedback though online, ultra-trace, gas-phase analysis of the small molecules emitted when the mixture is extruded, benefiting process development and optimization, as well as continuous process monitoring and control.
High-Throughput Screening of Polypropylene Polymer using Untargeted Headspace-SIFT-MS Analysis
This application note describes how SIFT-MS coupled with multivariate statistical analysis can be utilized for rapid screening of pelleted virgin and recycled polypropylene using an untargeted “fingerprinting” approach. Automated headspace-SIFT-MS analysis can classify and qualify polypropylene samples at throughputs of over 230 samples per day, offering great potential for rapid screening of recycled polypropylene feedstock for FCM applications. Adoption of SIFT-MS supports product quality and enhances sustainability.
Analysis of Volatile Residues in Polymers by SIFT-MS
This application note reviews polymer analysis applications of automated headspace-SIFT-MS. Rapid quality assurance/quality control (QA/QC) screening of over 220 samples/day can be conducted using targeted or untargeted analysis, while quantitative volatile impurity analysis is achieved efficiently using multiple headspace extraction (MHE)-SIFT-MS.
Rapid Analysis of Residual Solvents and Volatile Impurities for High-Throughput CDMO Workflows
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.