Pharma and CDMO

Real-time VOC analysis for pharma and CDMO applications. SIFT-MS delivers high-throughput solutions that increase your capacity and operational efficiency in residual solvent analysis, nitrosamine characterization, ethylene oxide and impurity detection, and detergent and sterilization monitoring.

Pharmaceutical Industry Applications Of Sift-Ms

High-Throughput Formaldehyde Analysis in Air Using Direct Mass Spectrometry

Routine Analysis 4: Direct MS Simplifies Analysis of Challenging Compounds

Rapid Screening of Volatile Compounds in Paperboard using Static Headspace-SIFT-MS

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.

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.

This preliminary evaluation demonstrates that SH-SIFTMS has the ability to provide odor ratings of paperboard samples.

Dr Perkins takes us through the attributes that make automated SIFT-MS an excellent tool for routine and R&D laboratories.

Dr Perkins takes us through the attributes that make automated SIFT-MS an excellent tool for routine and R&D laboratories.

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.

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.

This study demonstrates that SIFT-MS provides an alternative procedure to USP<467>.  Because SIFT-MS is inherently a rapid test technique (all sample components are simultaneously analyzed in about one minute per sample), this validated procedure can be used in organizations that require high-throughput testing, providing 17-fold daily throughput increase over GC-FID.

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.

SIFT-MS provides rapid, sensitive, and robust analysis of benzene and other contaminants in a wide array of commercial products. Integration with a headspace autosampler enables rapid screening of hundreds of samples per day.

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.

We asked David Light, CEO and Founder of Valisure, about his experience using SIFT-MS and how it impacted their dry shampoo safety study.  

Hear what Christopher Williams, Senior Manager of Analytical Development, Alcami Corporation, had to say about his experience using 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.

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.

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.

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.

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).

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.

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.

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).

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. 

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.

Syft Tracer^TM is the latest advancement in real-time, direct injection mass spectrometry (MS) built to solve the most difficult analytical challenges faced within a variety of industries and applications.  This advancement to SIFT-MS delivers trace-level detection sensitivity, unparalleled performance stability, superior selectivity, and highly reproducible, quantitative data.  Syft Tracer is optimized for high-throughput environments where continuous operation is the standard.  Never miss a product or environmental contamination event again.

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.

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.

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.

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.

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 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.

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.

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.