Application Notes: General

Throughout drug development, it is important to characterize and quantify pharmaceutical compounds and any associated metabolites to ensure proper drug safety and efficacy. LC-MS/MS techniques are predominantly used for such analyses because they provide a comprehensive outlook and can offer a sensitive and selective approach for the quantification of compounds. However, limited deep fragment coverage and sensitivity challenge the confident identification and quantification of metabolites and drug products. Here, alternative fragmentation paired with a highly sensitive QTOF system was employed for comprehensive data collection to properly identify metabolites and quantify complex peptide therapeutics.

• The identification of drug metabolites is a critical step in drug development due to their impact on drug efficacy and safety. LC-MS platforms provide good selectivity and sensitivity making it the preferred technique for metabolite identification. Here, metabolite identification was performed using unique fragments from EAD and CID spectra. Fragment information from EAD and CID spectra were processed in a single result file to achieve confident structure assignment of and localization of metabolites.

Learn about the end-to-end solution for metabolite identification from method development to analysis.

Discover how the targeted metabolomics screening workflow employing integrated SCIEX OS Software with the X500 QTOF System can benefit your lab.

This technical note describes the identification of pioglitazone phase 1 metabolites from a hepatocyte incubation using comprehensive spectral data from an orthogonal fragmentation technique. More informative MS/MS spectra provided by EAD aided in the software-based identification of phase 1 metabolites to support drug metabolism studies.

This technical note demonstrates the comprehensive characterization and confident identification of glucuronide metabolites from hepatocyte incubations of midazolam.

This Technical Note presents AEX as a refined and more robust alternative to commonly applied analytical workflows for encapsulation efficiency determination.

Improve analysis of betamethasone derivatives with CORTECS™ Premier C8 Columns featuring MaxPeak™ HPS Technology for sharper peaks and better analytical performance.

Improve validated HPLC methods by switching from fully porous to CORTECS™ Premier C18 5 µm Columns to boost throughput, cut solvent use, and enhance method greenness.

CDMS is reshaping the characterization of complex biotherapeutics by enabling precise analysis of large, heterogeneous biomolecular complexes and gene therapy vectors. This article explores how CDMS enhances resolution in quality assessments across biotherapeutic development and structural biology research—surpassing the capabilities of conventional analytical techniques.

In “Advances in Biopharmaceutical Analysis,” we highlight the latest developments in biopharmaceutical analysis, tackling topics such as advancing capillary column technologies for high-throughput microscale separations, using machine learning (ML)-based workflows for predicting oligonucleotide separation characteristics, and the changing regulatory landscape thanks to the integration of AI in biopharma for improving chromatographic peak integration.

Quantitative protein expression analysis is essential for advancing mRNA therapeutics, providing the data needed to confirm effective and targeted protein production. This article explores key assay development strategies, analytical challenges, and the application of advanced liquid chromatography-mass spectrometry (LC-MS) techniques to achieve precise and reproducible quantitation of proteins expressed from mRNA therapies.

This article demonstrates the suitability of ultrapure water from a Milli-Q® water system equipped with VOC-Pak® point-of-use cartridge for sensitive VOC analysis. This water is free of 58 VOCs evaluated, making it optimal for Purge and Trap GC-MS analysis of these compounds.

Nitrosamine contamination in pharmaceuticals has become a major regulatory concern due to their potent carcinogenicity, requiring ultra-trace-level detection to ensure patient safety. Advanced LC-MS/MS workflows provide the necessary sensitivity, selectivity, and robustness to accurately quantify nitrosamine drug substance-related impurities (NDSRIs), even within complex pharmaceutical matrices. Case studies with betahistine, orphenadrine, and chloropyramine demonstrate how streamlined LC-MS/MS strategies can reliably detect and confirm nitrosamine impurities well below regulatory thresholds.

Applying Analytical Quality by Design (AQbD) principles to impurity method development enables robust, science-based strategies for characterizing and controlling critical quality attributes in protein therapeutics. This webinar will present a case study on developing a fluorescence-based (FLR) method for quantifying Mannose-5 glycans, demonstrating how risk-based design and systematic evaluation of method parameters enhance reliability, reproducibility, and product understanding across the biopharmaceutical lifecycle.

This white paper covers the determination of nitrosamine impurities in pharmaceutical API’s and addresses issues associated with DMF and NDMA co-elution.

This case study highlights how a pharma company had a problem with low-to-medium task management and how Avantor Services was a solution deployed to meet the challenge with favorable results.

Every delay risks compromising critical samples, derailing progress, and forcing teams to start over. This video follows Ahmed, a scientist working in process development for drug production, as he navigates the challenges of sourcing ultra-high purity solvents, consumables, and chromatography columns for LC-MS analysis.

This article focuses on the important column selection decisions that are required for reversed-phase separations involving large biomolecules such as proteins.

This catalogue provides a comprehensive view of all our premium quality ACE columns for your HPLC and UHPLC needs.

This application note describes the separation of the 20 standard PFAS according to Directive (EU) 2020/2184 in only eight minutes.

High Throughput Quality Control (HTQC) is essential for laboratories analyzing dozens, hundreds, or even thousands of samples daily. This application note explores the critical elements necessary to achieve speed, reliability, and automation in high-throughput analysis. Find out how integrating advanced techniques—focused on increasing speed, sample throughput, and parallel processing—results in a robust system capable of improving your daily sample volume

n this application note, a USP monograph is modernized to a shorter column using 5 µm particles, which can be allowable under USP <621> as long as the N value is within the guidelines. By using highly efficient CORTECS 5 μm particles, this type of modernization is possible and reductions in solvent usage and run times are achieved

In this work the development of two key attributes of the 5um CORTECS Columns is examined. First column efficiency is compared across CORTECS and other solid-core 5 μm columns. Next scalability from sub-2 μm to 5 μm particles is examined between the CORTECS Column lines and competitive column lines. It was found that CORTECS columns have higher efficiency compared to other solid-core columns and that CORTECS particles are fully scalable.

Characterizing intact biotherapeutics such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) under physiological conditions is essential for understanding their critical quality attributes. This paper will examine several advanced chromatographic and detection solutions—including SEC, HIC, affinity chromatography, MALS, and HRMS—to support structural analysis, molecular weight determination, and DAR quantification.

The first charged aerosol detector (CAD) was introduced in 2005. Nearly twenty years later, this near-universal detector has become an indispensable tool in the analytical chemist’s quantitative arsenal. This paper explores the CAD’s origin story, its adoption into everyday use by separation scientists, and its comparison to evaporative light scattering detector (ELSD). Technical highlights will include how parameters such as evaporation temperature influence application versatility, and how the power function impacts linearity and response behavior.