PHARMACEUTICAL APPLICATIONS - SYFT TECHNOLOGIES

Importance of the Topic

Volatile organic compounds (VOCs) and trace gases pose significant safety and compliance risks in pharmaceutical manufacturing. Their presence at unsafe levels can compromise product quality, threaten patient health, and lead to costly recalls, brand damage, and regulatory penalties. Rapid, sensitive detection of these compounds is therefore critical to sustaining high standards in production, packaging, and supply chain operations.

Objectives and Overview of the Study

This whitepaper presents key pharmaceutical applications of Selected Ion Flow Tube Mass Spectrometry (SIFT-MS). It highlights how SIFT-MS addresses challenges in analyzing small polar compounds, residual monomers, solvents, and packaging contaminants. Through case examples, the document demonstrates improvements in sensitivity, selectivity, and throughput compared to conventional techniques.

Methodology

SIFT-MS employs soft chemical ionization with reagent ions to quantify VOCs and permanent gases in real time without preconcentration or derivatization. Eight rapidly switchable reagent ions — H3O+, NO+, O2+, O-, O2-, OH-, NO2-, and NO3- — react predictably with analytes in a controlled flow tube. Resulting product ions are detected by a quadrupole mass filter and quantified at sub-ppb and even part-per-trillion levels.

Used Instrumentation

SIFT-MS instruments from Syft Technologies integrate:

• A microwave plasma source generating eight reagent ions
• A flow tube for controlled ion–molecule reactions
• Quadrupole mass filters for ion selection
• A sensitive detector for real-time quantitation
• Autosampler compatibility for high throughput

Main Results and Discussion

SIFT-MS delivers:

• Direct detection of formaldehyde, acetaldehyde, formic acid, and other small polar compounds at sub-ppbv concentration
• Rapid screening of residual monomers and byproducts in drug delivery devices such as inhalers and ophthalmic systems
• Fast analysis of residual solvents in finished pharmaceuticals without chromatographic separation
• Enhanced packaging testing across polymers, adhesives, and print materials with high humidity tolerance
• Wide dynamic ranges and linear responses, enabling one instrument to handle diverse analytical tasks

Benefits and Practical Applications

SIFT-MS offers significant advantages for pharmaceutical quality control and process monitoring:

• High sample throughput by eliminating chromatography
• Immediate quantitation and alerting for quality issues
• Reduced cost per analysis and faster time to result
• Comprehensive VOC and gas impurity profiling in raw materials, production streams, and packaging
• Improved risk management and product release decisions

Future Trends and Opportunities

Advances in SIFT-MS are expected to expand real-time Process Analytical Technology (PAT), inline monitoring, and automated quality control. Enhanced reagent libraries, miniaturized instruments, and integration with advanced data analytics and machine learning will further streamline pharmaceutical development, manufacturing, and regulatory compliance.

Conclusion

SIFT-MS represents a transformative analytical tool for the pharmaceutical industry by combining ultra-sensitive, selective, and high-throughput detection of VOCs and gases. Its capacity for direct, real-time analysis across multiple applications supports more robust quality assurance, accelerates decision-making, and reduces operational risks.

References

• Syft Technologies 2017 PDF Brochure Pharmaceutical Industry Applications of SIFT-MS