This review article discusses scientific rationales and current best practices in the pharmaceutical industry for performing chromatographic peak purity assessments (PPA). These activities are associated with the development and validation of liquid chromatographic (LC) stability-indicating analytical methods applicable to regulatory submissions of small-molecule drug candidates. The discussion includes a comprehensive overview of the PPA-related regulatory and scientific landscape and common industry approaches to obtain PPA results, as well as the strengths and weaknesses of PDA-facilitated ultraviolet (UV) PPA and other PPA techniques.
The European Commission's regulation on maximum levels for certain contaminants in food highlights the need for precise and reliable methods to quantify per- and polyfluoroalkyl substances (PFAS) in various food matrices. This article discusses development and validation of a robust method for analyzing 21 PFAS compounds in chicken eggs using solid-phase extraction (SPE) and liquid chromatography–mass spectrometry (LC–MS).
This article presents a new hydrophilic SAX hybrid monolithic column prepared by in‑capillary coating 5 μm bare silica particles with functional organic polymers. After preparation conditions were investigated and selected, the resulting column was characterized in detail.
FoodOmicsGR_RI aims to characterize unique Greek products and highlight their value and quality using cutting-edge omics technology.
An overview of different approaches for the qualitative and quantitative analysis of polysorbates.
The analysis of contaminants found in environmental waters and originating from personal care products using metalorganic frameworks (MOFs) combined with liquid chromatography (LC) is described. This work expands the use of MOFs from gas chromatography to LC and also meets the requirements of green analytical chemistry.
HS-GC analysis is presented as an excellent method for the analysis of high volatile components in e-liquids. For the analysis of semivolatile ingredients, an additional sample preparation step is proposed based on a LLE followed by a freeze-out of the matrix components.
FoodOmicsGR_RI aims to characterize unique Greek products and highlight their value and quality using cutting-edge omics technology.
The identification and quantification of sulphur are real analytical challenges, demanding selective and sensitive methods. Analysis of products such as beer, wine, coffee, and vegetables are discussed.
Microextraction techniques have evolved since their appearance three decades ago, moving toward the use of greener and sustainable materials and solvents.
GLP helps ensure the quality of different studies during drug development. Here, the authors outline practices relevant to analytical and bioanalytical chemists.
A micro-pillar array format for mapping the proteome of human stem cell-derived liver organoids using timsTOF–MS is presented.
The 14th Congress of the French-speaking Association for Separative Sciences (SEP21) will take place at the Porte de Versailles in Paris, France, from 5–7 October 2021. This preview explores what visitors can look forward to from the conference.
High performance anion-exchange chromatography coupled with pulsed amperometric detection (HPAEC-PAD) is a potential method of choice for the analysis of carbohydrates.
Adhesives often contain toxic materials like residual monomers; here, we demonstrate quantitative analysis of residual monomers in adhesives using GC–MS.
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Are you working with LC and GC in pharmaceutical discovery, development, or QC/QA? Looking for higher speeds, increased sensitivity, reduced solvent consumption and automated sample prep/collection?
It is of paramount importance that companies develop their in-house macromolecular separations expertise, not only polymer manufacturing companies but also those employing macromolecules for any of a host of applications, from drug-delivery and tablet coatings to ink-jet printer formulations and food additives, to name but a few.
The article discusses the classification and characterization of GC×GC column sets based on polarity and orthogonality, introducing a standardized approach using a reference mixture called the Century Mix to evaluate the selectivity and performance of these column sets.
Untargeted GC–MS metabolomics with sample derivatization is shown here to be effective for measuring the chemical profiles of traditional and plant-based meat products.
Long chain fatty acids (LCFAs) function as a source of metabolic energy, substrates for membrane biogenesis, and storage of metabolic energy. Oxylipins, oxygenated derivatives of LCFAs, regulate the activity of many cellular processes. Existing methods for the analysis of LCFAs and oxylipins have limited compound coverage and sensitivity that, therefore, prevent their application in biological studies. In this work, we developed a high-throughput LC–MS method for analysis of 51 LCFAs and oxylipins. LCFAs and oxylipins were first extracted from biological samples via solid-phase extraction. The extracted molecules were analyzed by targeted comparative metabolomics. Saturated and monounsaturated LCFAs were analyzed in single ion reaction mode, while polyunsaturated LCFAs and oxylipins were analyzed in multiple reaction monitoring mode. Using this method, we successfully quantified 31 LCFAs and oxylipins from mouse livers.
Even compared to other biopharmaceuticals, chimeric antigen receptor (CAR) T-cell therapies are particularly complex. Mass spectrometry (MS)–based process analytical technologies can be a powerful tool in identifying and monitoring key attributes throughout the manufacturing process.
How to lower the limits of quantitation as the regulatory landscape continues to evolve.
A rapid LC–MS method using ESI coupled with SIM-MS for analysis of humulone and isohumulone content in beer is described.
An overview of mRNA-based vaccine production and a discussion on the methods that are currently in use to check the quality of these vaccines.
In this study, a probe electrospray ionization coupled to mass spectrometry (PESI-MS) method for ultra-rapid determination of MtF in plasma by isotope dilution was developed.
The complexity and challenges of developing, manufacturing, and controlling cell therapies offer today’s chromatographic scientists new opportunities to join the journey of discovery and innovation needed to develop and commercialize this new drug modality. This article explores the latest developments and highlights the importance of new capillary electrophoresis–mass spectrometry (CE–MS)-based approaches to understand the efficiency of cell therapy production.
Recent Advances in Gas Chromatography Event Preview and other important events for chromatographers
This article provides a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and related public quality standards.