An UHPLC–MS research prototype instrument was built to improve the resolution power and the usability of conventional LC–MS hyphenated instruments for routine analyses in pharmaceutical applications.
Ion mobility–mass spectrometry (IM–MS) has become a cornerstone of bioanalytical laboratories. New developments could lead to its widespread adoption for regulated bioanalysis methods such as anti-doping testing for anabolic steroids in athletes.
This poster describes GenNext’s first-in-class instrument for fully automated protein footprinting that delivers highly precise and accurate quantification for numerous higher order structure (HOS) mapping experiments.
This technique achieves highly reproducible and fast analysis of organochlorine pesticides in water by coupling automation with the use of a disperser solvent.
A novel method to simultaneously characterize the capping and poly(A) tail for therapeutic mRNA in a single sample preparation workflow is described.
Reducing matrix effects during LC–MS/MS bioanalysis is paramount. Improving sample preparation techniques is the best way to combat this issue.
This paper describes the content of a well-written analytical procedure for regulated high-performance liquid chromatography (HPLC) testing. A stability-indicating HPLC assay for a drug product illustrates the required components for regulatory compliance, including additional parameters to expedite a laboratory analyst’s execution.
The authors developed a new analytical HPLC method using a silica hydride-based column to analyze mushrooms.
The editors of BioPharm International spoke with Christine Rozanas, PhD, global product marketing manager at Cytiva, to discuss the advantages and persistent challenges with implementing continuous downstream chromatography.
Laboratories use proficiency tests (PTs) to comply with their accreditation requirements and evaluate analysts’ performance. Laboratories regard PTs as a burdensome chore that must be successfully completed to satisfy internal or external compliance or accreditation requirements. PTs are an integral part of a quality management system (QMS) under quality assurance and control (QA/AC). Understanding the core components of the QMS is an important part of passing any PT test. Unacceptable PT results may have little to do with the result itself but reflect the use and application of statistics, standards, and methods.
This is the first article in a four-part series exploring the quantitative assessment of drugs and their metabolites in biological fluids (such as blood, plasma, and urine) and tissue homogenates using liquid chromatography–mass spectrometry (LC–MS).
This article explores the analytical challenges associated with HCP monitoring and reviews recent advances in HCP characterization, with special emphasis on high performance liquid chromatography mass spectrometry (HPLC–MS)-based methods and HCP enrichment techniques.
A new fragmentation approach—tunable electron-activated dissociation (EAD) tandem mass spectrometry (MS/MS)—offers a solution to better improve the detection and characterization of impurities in lipid nanoparticles and impurities in other biopharmaceutical modalities.
Successful GC analysis requires careful control of carrier gas. Here, we explain how to measure and control flow rate, use constant pressure vs. constant flow, and more.
Scientists recently developed new GC/LC-Q-TOF/MS-based method for determining pesticides in Angelica sinensis, a traditional Chinese medicine.
The UHPLC–MS/MS method can accurately determine the presence of these illegal feed additives in swine tissues.
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 authors introduce a new high-throughput approach for analyzing environmental micropollutants.
A fast ultrahigh-pressure liquid chromatography (UHPLC) method, with low solvent consumption, is described for the determination of coenzyme Q10 in a variety of complex formulations. This method exhibits good linearity, reproducibility, accuracy, recovery, and specificity, while resulting in an acceptable limit of detection (LOD) and limit of quantification (LOQ).
Correlation, clustering, and color projection techniques exploit the ability of the human brain to identify patterns from huge amounts of visual information. This process can provide a life raft for a weary chromatographer who is drowning in data.
When the unique shape-selective properties of PGC are appropriately identified, PGC stationary phases can be harnessed for fine separations of structurally related compounds.
We explore the impact of two different stationary phases and ion-pair reagents on the retention behavior of a therapeutic peptide using reversed-phase liquid chromatography. This information is of fundamental importance for the development of reliable, selective, and fast analytical methods able to separate and identify the target peptide.
The occurrence of convex-upward van Deemter curves is rare but not unusual in chiral liquid chromatography. In this work, this behaviour, experimentally observed for the more retained enantiomer of a chiral sulfoxide on a polysaccharide-based CSP, is explained.
Liquid chromatography–mass spectrometry (LC–MS) is a popular technique for the analysis of wine. This article gives an overview of wine analysis and new insights this technique has revealed regarding the composition of wine, possible health benefits, customer safety and the understanding of winemaking processes.
A supported liquid extraction (SLE) and fast gas chromatography–tandem mass spectroscopy (GC–MS/MS) method, used in multiple reaction monitoring (MRM) mode, was developed for the analysis of semivolatile organic compounds (SVOCs) in environmental samples, according to the updated EPA Methods 625.1 and 8270E. This method requires minimal sample handling and yields significant throughput and productivity gains in the laboratory.
Evaporation-free extraction (no drying down) is highly desirable because of its reduced cost and pollution, higher speed, and less possibility for contamination and conversion. Presented in this article are four types of evaporation-free extraction that are widely applicable. The first one is for the determination of didanosine over the range of 25.02–2502.00 ng/mL by injecting solid-phase extraction (SPE) eluate directly. The second is for the determination of betamethasone phosphate over the range of 2.51–250.60 ng/mL by injecting SPE eluate after pH adjustment. The third is for the determination of sumatriptan over the range of 0.99–99.40 ng/mL based upon SPE with high organic washing and low organic elution. The fourth is based upon automated dilution after protein precipitation for the determination of raloxifene-4'-glucuronide and raloxifene-6-glucuronide over the ranges of 2.02–202.40 ng/mL and 0.40–39.95 ng/mL, respectively.