Pharmaceutical Drug Delivery Devices

Syft supports product quality assurance by quantifying VOCs and SVOCs in real-time so that issues can be dealt with immediately.

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

Brochure

Pharmaceutical Applications

Pharmaceutical Industry Applications Of Sift-Ms

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Whitepaper

Formaldehyde in Air (sample bags)

High-Throughput Formaldehyde Analysis in Air Using Direct Mass Spectrometry

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Webinar

Rapid, Simplified Residual Solvent and Volatile Impurity Analysis Using SIFT-MS

Volatile impurities occur frequently in pharmaceutical products and packaging and are often of significant concern due to their toxicity.
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Application Note

Formaldehyde Thermal Extraction with TD-SIFT-MS

Time-Resolved Thermal Extraction of Residual Formaldehyde Using Thermal Desorption-SIFT-MS

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Application Note

Pharma Method Validation - Formaldehyde

Validation of a High-Throughput SIFT-MS Method for Analysis of Formaldehyde Leachate

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Application Note

Residual Monomer Analysis

High-Throughput Residual Monomer
Analysis, Using SIFT-MS

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Webinar

Routine Analysis 3: SIFT-MS Method Development and Validation

SIFT-MS Method Validation

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Webinar

Analysis of Volatile Emissions from Polymers and Paperboard

Food and pharmaceutical products are susceptible to contamination from packaging – whether from polymeric materials, printing inks or paperboard.
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Application Note

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.

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Application Note

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.

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Application Note

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.

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Webinar

Feedback from a CDMO SIFT-MS User

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

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Application Note

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.

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Application Note

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.

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Application Note

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.

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Webinar

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.

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Webinar

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).

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Application Note

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.

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Application Note

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.

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Application Note

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).

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Document

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. 

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Webinar

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.

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