- Comprehensive analysis, including inorganics and chromatographically challenging compounds
- Automated gas and headspace analysis with extremely high-throughput (>100 samples / hour)
- High sensitivity and wide linearity range
- Intuitive software and fast method development
- Flexible sample delivery options, including automation and area sampling
PHARMACEUTICAL INDUSTRY APPLICATIONS OF SIFT-MS
Volatile organic compounds (VOCs) are widely utilized in various pharmaceutical manufacturing processes and in other parts of the supply chain (e.g. polymer manufacture and packaging). Many VOCs have adverse health effects and unfortunately, find their way into the pharmaceuticals themselves. At unsafe levels, they can result in product recalls, brand damage, and lawsuits.
Selected ion flow tube mass spectrometry (SIFT-MS) is a robust analytical technique that both simplifies testing of challenging compounds (e.g., formaldehyde) and facilitates more frequent component and product testing through greatly enhanced sample throughput. SIFT-MS quantifies VOCs directly in real time to sub-part-per-billion (ppb) concentrations, so that product issues are detected earlier and resolved immediately, delivering economic benefits to all stakeholders. SIFT-MS represents a major breakthrough for the pharmaceutical industry.
- Formaldehyde measurement is critically important for many products, yet so difficult to analyze rapidly
- Rapid detection of – and response to – chemical issues is thwarted by slow analysis
- Conventional analytical techniques greatly hinder implementation of more extensive quality control testing due to low throughput
- Multiple instruments are necessary to achieve comprehensive air quality monitoring for hazardous chemicals
How Syft can help
- Respond to issues immediately due to instant, direct analysis
- Sensitive, quantitative analysis of all VOCs (including formaldehyde) and many inorganic gases with one instrument, delivering greater efficiency
- Faster evaluation of residual VOCs in pharmaceuticals and packaging material emissions
- Improved quality control through analysis of more samples at much lower cost per sample
- Simple, cost-effective air quality monitoring in production facilities
SIMPLE ANALYSIS OF SMALL POLAR COMPOUNDS
Analysis of polar and reactive species – such as formaldehyde, acetaldehyde, and formic acid – is slow and complicated when using conventional chromatographic methods. 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.
Applications of SIFT-MS for analysis of challenging compounds include:
- Residual monomers and byproducts
- Residual solvents in pharmaceuticals
- Packaging impurities.
RESIDUAL MONOMER 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).
Benefits of SIFT-MS:
- Very high throughput screening through 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.
ENHANCED PACKAGING TESTING
With its ability to analyze a very wide range of compounds rapidly, SIFT- MS revolutionizes packaging testing across diverse materials including:
- Print products
Benefits of SIFT-MS:
- Increased product testing through faster analysis, provides early warning of quality issues in packaging materials
- Multiple packaging applications are conveniently and simply tackled by one instrument
- High selectivity from eight rapidly switchable reagent ions
- High robustness to humidity, greatly simplifying testing procedures for high moisture systems.
RAPID RESIDUAL SOLVENT ANALYSIS
A wide variety of solvents are used during manufacture of pharmaceuticals, but regulations strictly control permissible concentrations in the finished product. SIFT-MS provides a very rapid and highly sensitive solution to the detection of VOC residues in pharmaceuticals that are not easily monitored by other technologies.
Benefits of SIFT-MS:
- Direct analysis through elimination of chromatographic separation, which is ideal for detection of volatile solvents.
- High selectivity via multiple rapidly switchable reagent ions.
- Very high throughput VOC screening coupled with high sensitivity provides rapid warning of quality issues and greatly reduces the test cost per analysis.
- Wide linear and dynamic ranges allows one instrument to be applied to multiple analytical tasks.
Selected Ion Flow Tube Mass Spectrometry – SIFT-MS platform capable of high-throughput gas and headspace analysis for VOCs and inorganic gases.
Gerstel MPS autosampler
Multi-purpose sampler available with wide range of accessories to meet diverse automated analysis needs.
Gerstel Maestro software
Powerful control and scheduling software for the Gerstel MPS.
Autosampler integration kit
All the hardware required for integrating the Voice200ultra and the Gerstel MPS autosampler.
Multi-port inlet enables multiple sample streams to be analyzed (e.g. for facility air quality monitoring).
Software package for viewing and analyzing SIFT-MS data from multiple instruments, customizing analyses, and interacting with the Voice200ultra.
Access detection and quantitation parameters for over 1000 compounds to leverage the diverse capability of the platform.
|Pharmaceutical Applications Brochure|
|White Paper – Formaldehyde Analysis in Air Using Direct Mass Spectrometry|
|White Paper – Continuous Headspace Analysis|
|Residual Solvent and Residual Monomer Analysis|