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.

SIFT-MS delivers high-throughput solutions that eliminate bottlenecks in development, production, and QA/QC environments.

The real-time data output of SIFT-MS significantly shortens time to data and increases sample throughput. Analytical bottlenecks in pharma and CDMO applications can be overcome, increasing capacity and operational efficiency in applications such as residual solvent analysis, nitrosamine characterization, ethylene oxide and impurity detection, and detergent and sterilization monitoring.

Pharma and CDMO applications and use cases

Small Polar Molecules

SIFT-MS simplifies detection of small polar species by analyzing them directly from gas or headspace to sub-ppbV concentrations, without requiring derivatization or preconcentration.

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Residual Solvent Analysis

SIFT-MS provides rapid characterization of compounds that are not easily monitored by other technologies.

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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.

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Packaging Testing

SIFT-MS revolutionizes packaging testing across diverse materials with its ability to analyze a very wide range of compounds rapidly.

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Syft is your answer in the Pharmaceutical industry

Industry issue

For pharmaceutical companies investing in scale-up of their manufacturing processes, the associated scaling of residual solvent testing using the USP<467> procedure requires significant upscaling of analysis capacities. This involves increased investments in qualified personnel, lab space, validation procedures and maintenance as well as higher overall instrument acquisition and running costs.

Competitive benefit

The validated SIFT-MS procedure meets the acceptance criteria in USP<1467>, and with 17-fold higher sample throughput, addresses current scale-up issues for residual solvent testing in the pharmaceutical industry.

Industry impact

Since SIFT-MS uses direct, chromatography-free analysis, practical issues for the front-end separation are eliminated, resulting in a robust and reliable analytical result that is easily obtained and requires less qualified personnel. Capacity increase can thus be reached with just a single automated SIFT-MS instrument.

Sample customers


Pharmaceutical 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 Volatile Impurity Analysis in Pharmaceutical Products Using SIFT-MS

SIFT-MS is a new tool for real-time, selective and economical trace gas and headspace analysis.
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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

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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Webinar

Routine Analysis 1: Why Labs and CROs Should Adopt Direct MS

Sample throughput is often a critical bottleneck when analyzing volatiles in contract testing or research laboratories.
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Webinar

Routine Analysis 4: Direct MS Simplifies Analysis of Challenging Compounds

Direct mass spectrometry (direct MS) facilitates faster method development and validation, plus it provides high throughput for routine analysis.
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Webinar

Syft Application Talks 5: Determination of the Supercritical Carbon Dioxide Extraction End-Point

For the majority of pharmaceuticals, the final step in drug substance isolation relies on drying for removal of organic solvents used in upstream synthesis, to deliver a pure API fit for downstream formulation and drug product manufacture.
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Webinar

Part 4: Biomedical and Pharma

In this webinar, we continue our seven-episode series, which outlines the diverse applications of the SIFT-MS technique.
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Webinar

Online Demonstration: Pharmaceutical Applications

This online demonstration showcases the pharmaceutical industry applications of SIFT-MS. SIFT-MS is a technique that utilizes chemical ionization to quantify volatiles and inorganic gases in samples.
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Webinar

Pharmaceutical Method Validation for SIFT-MS

Volatile compounds are common impurities in pharmaceutical products and are often of concern due to their toxicity.
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Application Note

Simple, Rapid Analysis Of N-Nitrosodimethylamine (NDMA) Impurity In Ranitidine 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.

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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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Application Note

Rapid Residual Solvent Analysis Validation Of An Alternative Procedure For USP Method <467> Using SIFT-MS

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.

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Application Note

Simple Rapid Analysis of NDMA in a Recalled Valsartan Product Using SIFT-MS

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.

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Application Note

High-Throughput, Quantitative Analysis of Benzene in Personal Care Products using Headspace-SIFT-MS

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.

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Application Note

Real-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.

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Webinar

A Consumer Safety Expert Shares His Experience with SIFT-MS

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

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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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