Agilent Technologies, Inc.

Articles by Agilent Technologies, Inc.

Chemical characterization of medical devices, including drug-device combination products, is crucial for ensuring regulatory compliance and patient safety by identifying and quantifying chemicals that may interact with the human body. This paper explores current trends, best practices, and regulatory developments in extractables and leachables (E&L) testing for medical devices.

This application note demonstrates the use of the Agilent 1260 Infinity II Hybrid Multisampler for the analysis of per- and polyfluorinated alkyl substances (PFAS). The Hybrid Multisampler in feed injection mode was used with optimized Feed Speed for the sample injection to trap and enrich the compounds on the column. This avoided peak broadening and breakthrough of the early-eluting polar PFAS compounds. The less polar PFAS compounds can be enriched for more sensitive quantification.

The US EPA has released interim health advisory limits (HALs) of 4 and 20 pg/L in drinking water for the PFAS perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), respectively. This application note addresses PFAS testing at these challenging new levels in aqueous samples using optimized solid-phase sample extraction and LC/MS/MS analysis with an Agilent 1290 Infinity II liquid chromatography (LC) system coupled to an Agilent 6495C triple quadrupole (TQ) mass spectrometer.

Labile post-translational modifications are better preserved using ECD than conventional MS fragmentation techniques such as collision-induced dissociation (CID). Common modifications, such as glycosylation and phosphorylation, can impact the safety, efficacy, and binding activity of monoclonal antibodies but are challenging to identify. Stephen Sciuto from Agilent Technologies and colleagues analyzed tryptic digests of NIST mAb and Infliximab using an 6545XT Q-TOF mass spectrometer in ExD or CID mode. ECD provided higher sequence coverage than CID, reaching 100% for glycosylated peptides in Infliximab. The ability to pinpoint glycosylation sites using fragment ions demonstrates the power of ECD for characterizing glycopeptides.

The first reported combination of microdroplet reactions with ECD fragmentation offers a quicker way to analyze monoclonal antibodies for disease treatments. Thomas Walker from Agilent Technologies and co-workers demonstrate the use of an Agilent Jet Stream electrospray ionization source to facilitate in-spray chemical reduction and protease digestion of monoclonal antibodies. Downstream fragmentation of the microdroplet reaction products with ECD provided rapid characterization of intact antibodies in minutes. Efficient ECD fragmentation yielded rich sequence information including evidence of disulfide bond connectivity and confirmation of key sequences called complementary determining regions. These results highlight this method’s potential for fast and cost-effective antibody characterization with minimal sample preparation.

Photodegradation of plastic products is known to accelerate weathering and the resulting release of chemical additives and particles to the environment, however these processes are complex. Here, eight different plastic consumer products were leached in double-distilled water under exposure to strong ultraviolet (UV) light for ten days, and the chemical composition of the leachates was compared to their respective dark controls. The leachates and plastic particles were investigated with a wide battery of chemical-analytical tools to broadly characterize the underlying processes and possible hazards. These covered (a) metal(loid) analysis, (b) microplastic analysis, (c) analysis of >70 organic target analytes and (d) nontargeted screening of the extracts.

Microplastics are defined as small plastic particles between 1 µm and 5 mm in size. Due to poor waste management and plastic pollution, they are now documented to be ubiquitous in the environment.1,2 However, pathways of dietary exposure to microplastics are not yet fully understood. The consumption of bottled water has been calculated to increase by 7% annually, with an estimated mean total global consumption of bottled water to be 513 billion liters by 2025. This study demonstrates how the Agilent 8700 Laser Direct Infrared (LDIR) Chemical Imaging System can accurately identify and quantify the presence of microplastics in bottled drinking water. This study also shows the capability of the Agilent Cary 630 FTIR spectrometer to investigate the source of microplastic contamination.

Reports of the omnipresence of microplastics have mainly focused on their presence in the environment, but there is a growing interest in investigating the health impacts of microplastics. Many people would assume that infants' exposure to microplastics would be limited. However, infant formula was found to be a possible exposure pathway. Extracting and isolating microplastics from infant formula can be difficult due to the range of formulations, ingredients, and components, such as fats, proteins, minerals, vitamins, and sugars. This application note demonstrates the importance of quality control in microplastics analysis. The study also shows how the Agilent 8700 Laser Direct Infrared (LDIR) Chemical Imaging System can accurately identify and quantify microplastics in infant formula.

This comprehensive peer-reviewed set of more than 600 definitions covers topics of interest for the biopharmaceutical and gene therapy subjects of genetics, therapeutics, drug development, clinical medicine, and the analytical science tools used for characterization of drugs. This glossary serves as a helpful reference to both novice and advanced scientists, engineers, and business executives involved with biopharmaceuticals and gene therapy technologies. Online sources of information for topics covered in this guide are also included for additional insights.

Agilent workflow solutions, designed for the food and beverages industry, serve as a comprehensive resource for testing alternative proteins. This compendium provides 15 applications across various domains, such as taste and flavor, nutrition, food quality, and food safety leveraging advanced analytical techniques like ICP-MS, LC/MS, GC/MS, and HPLC.