Extractables and Leachables Testing Service Based on High-Resolution GC-MS/MS

STEMart offers specialized Extractables and Leachables (E&L) Testing Services using High-Resolution GC-MS/MS (Gas Chromatography-Tandem Mass Spectrometry), an advanced technology designed to detect trace contaminants in packaging, drug delivery systems, and medical devices. In our laboratory, high-resolution GC-MS/MS plays a vital role in providing highly sensitive and precise identification of potential extractables and leachables, ensuring that products meet safety and regulatory standards. Our cutting-edge technology allows us to deliver reliable results for a wide range of industries, including pharmaceuticals, biotechnology, and medical devices.

GC-MS/MS operates by separating volatile and semi-volatile compounds using gas chromatography, followed by tandem mass spectrometric analysis for precise identification and quantification. The high-resolution capabilities of GC-MS/MS allow for the detection of extremely low levels of extractables and leachables, which may migrate from packaging materials or devices into pharmaceutical products. This technology is crucial for risk assessment and ensuring compliance with international regulatory requirements for safety and product integrity.

Leveraging our expertise in chemical analysis and the advanced capabilities of High-Resolution GC-MS/MS, STEMart offers a comprehensive range of extractables and leachables testing services. Whether you are testing packaging, drug products, or medical devices, our services provide the high-quality data necessary to ensure product safety and compliance.

What We Offer

• Extractables Profiling

We perform comprehensive extractables profiling using high-resolution GC-MS/MS, helping to identify potential contaminants that may migrate from packaging or manufacturing materials.

• Leachables Testing

Our leachables testing service focuses on identifying and quantifying substances that may leach into pharmaceutical products or medical devices over time, ensuring product safety and compliance.

• Risk Assessment for Drug Packaging

We offer E&L testing services tailored for pharmaceutical packaging, assessing the risk of contamination to ensure that packaging materials meet regulatory standards.

• Medical Device Extractables and Leachables Testing

Our service includes testing for extractables and leachables from medical devices to ensure biocompatibility and compliance with ISO and other regulatory guidelines.

Why Choose Us

• High Sensitivity and Accuracy

Our High-Resolution GC-MS/MS system provides exceptional sensitivity and accuracy, allowing us to detect even trace levels of extractables and leachables in complex matrices.

• Regulatory Expertise

Our E&L testing services are aligned with international regulatory standards, ensuring that your products meet all necessary safety and compliance requirements.

• Comprehensive Chemical Analysis

We offer extensive chemical analysis coverage, ensuring that all potential contaminants are thoroughly identified and quantified in your products.

Our Equipment

High-Resolution GC-MS/MS

This advanced system combines gas chromatography with tandem mass spectrometry, offering precise separation and detection of volatile and semi-volatile extractables and leachables in packaging, medical devices, and drug products.

Triple Quadrupole MS

Complementing our GC-MS/MS capabilities, this instrument delivers targeted quantification of specific extractables and leachables, ensuring accurate and reliable results in compliance testing.

Headspace GC-MS

This system is designed for the analysis of volatile organic compounds in sealed environments, offering precise detection of extractables and leachables from packaging and medical devices.

STEMart provides high-quality mass spectrometry services tailored to meet the specific needs of our clients. Our experienced specialists use advanced equipment and follow strict quality control measures to ensure accurate and reliable results. Contact us to learn more about our mass spectrometry services and how we can help you achieve your research goals.