High-resolution accurate mass spectrometry (HRAMS) using LC/MS/MS and GC/MS/MS delivers unmatched sensitivity and specificity for chemical characterization. At Invision Biomedical, we use these advanced tools to identify, quantify, and confirm even trace-level compounds—helping clients meet FDA and ISO 10993 requirements with confidence.
Our HRAMS systems provide unmatched sensitivity, capable of detecting compounds at parts-per-billion or even lower concentrations. This ensures that even the smallest trace impurities are identified before they become regulatory or safety concerns.
With both LC/MS/MS and GC/MS/MS platforms, we can analyze volatile, semi-volatile, and non-volatile compounds across a wide range of biomedical materials. This broad coverage enables comprehensive chemical characterization under one roof.
All results are generated and reported in formats that meet FDA and ISO 10993-18 guidelines. This minimizes delays in regulatory review and provides clients with documentation that is clear, defensible, and submission-ready.
By combining multiple chromatographic and mass spectrometry techniques, we can tailor our methods to the unique requirements of each device. This flexibility allows us to provide targeted solutions for complex testing challenges.
01
Device materials are carefully prepared under validated protocols to ensure representative extraction. This step maximizes recovery of potential compounds while maintaining the integrity of the sample.
02
Samples are separated into their chemical components using liquid or gas chromatography. This process provides a clean pathway for identifying compounds within complex mixtures.
03
Separated compounds are analyzed with precise mass-to-charge ratio measurements using HRAMS. This high-resolution analysis enables confident identification and quantification of known and unknown compounds.
04
Our scientists interpret the data in the context of toxicological thresholds and regulatory expectations. The findings are then delivered in detailed, regulator-ready reports that clearly support compliance.
High-resolution accurate mass spectrometry supports safety and compliance in a range of biomedical industries. This technology enables manufacturers to uncover trace contaminants, verify material purity, and support regulatory submissions.
It’s an advanced analytical technique that uses LC/MS/MS or GC/MS/MS platforms to detect, separate, and characterize chemical compounds with high precision.
Each platform targets different compound classes—LC/MS/MS excels with semi-volatiles and non-volatiles, while GC/MS/MS is ideal for volatile organics—ensuring complete coverage.
It provides the chemical characterization data needed to evaluate extractables, leachables, and impurities under ISO 10993-18 guidelines.
Our lab combines cutting-edge instrumentation with regulatory expertise, delivering clear, validated reports that withstand FDA and ISO review.
In 2015, Invision Biomedical added to its instrumental portfolio a powerful new “soft” ionization Atmospheric Pressure Gas Chromatography (APGC) interface at the front end of its quadrupole time-of-flight (QTof) mass spectrometer. The APGC interface includes a 7890 Agilent gas chromatograph and an APGC source. The APGC source is comprised of a heated line, an atmospheric pressure ionization (API) corona pin, and sample cone. Together these function to transport and focus the GC column eluent into the ionizing region around the API corona pin and finally direct the ion stream into the high vacuum ion optics of the Tof. Unlike traditional GC-MS platforms, ion formation in APGC occurs at atmospheric pressure in nitrogen gas and affords “soft” ionization yielding primarily molecular ions with minimal in-source fragmentation. The combination of APGC “soft” ionization with the sensitivity and mass accuracy of the high resolution QTof instrument affords analyte detection limits in the low parts per billion (ppb) and analyte mass accuracies in the low ppm.
Data with the precision and accuracy afforded by Tof detection are unattainable with conventional unit resolution GC-MS analyzers (e.g., single quadrupole instruments). Nonetheless, unit resolution GC-MS analyzers are used for the bulk of most standard volatile and semi-volatile analyses even though their unit mass accuracy makes it impossible to narrow down chemical formula candidates for an analyte to a practical number. Chemical identification with unit resolution mass analyzers depends almost entirely on mass spectral matching to 70eV electron ionization (EI) fragment libraries such as NIST and the WileyRegisty. Hence, if the mass spectrum of an analyte of interest is not present in these libraries then chemical identification is typically unachievable. Unfortunately, the mass spectra of many volatile compounds are not found in these fragment libraries, especially degradants, contaminants and by-products. With the mass accuracy of APGC QTof it is possible to narrow down any volatile analyte’s candidate chemical formulas to a short list that can ultimately lead to unambiguous identification.
Partner with Invision Biomedical for advanced LC/MS/MS and GC/MS/MS testing that provides the clarity and confidence you need for compliance.
