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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