April 26th 2024
Here are the top five articles that the editors of LCGC International published this week.
Separation Science in Drug Development, Part II: High-Throughput Characterization
August 1st 2015This installment provides an overview of high-throughput characterization techniques of drug leads to support small molecule drug discovery programs in a pharmaceutical company. A myriad of analytical chemistry techniques including separation science methodologies are used to confirm the structures and identities, quantitating the concentrations of stock solutions, and measuring key physicochemical properties of the new chemical entities (NCE). A case study is used here to illustrate the details of these applications in high-throughput characterization.
Challenges in the Determination of Protein Aggregates, Part II
July 1st 2015Here in part II of our series on assessing protein aggregation, we provide an overview of best practices for achieving this goal, including the importance of using a multimethod approach.Here in part II of our series on assessing protein aggregation, we provide an overview of best practices for achieving this goal, including the importance of using a multimethod approach.
Experimental results and method validation data from two analytical case studies of complex small?molecule pharmaceuticals illustrates the utility and advantages of UHPLC in high-resolution separations.
Challenges in the Determination of Protein Aggregates, Part I
January 1st 2015Most analytical approaches used for the determination of low-molecular-weight noncovalent aggregates in protein pharmaceuticals suffer from important limitations. This first part of this two-part column series discusses those limitations.
UHPLC and MS Techniques Aid in Pharmaceutical Research
November 22nd 2013LCGC recently spoke with Pauline Rudd of University College, Dublin, and The National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland, about her work using ultrahigh-pressure liquid chromatography (UHPLC) for the characterization of protein glycosylation.
Determination of Genotoxic Impurities in Pharmaceuticals
May 2nd 2013The determination of genotoxic impurities (GIs) in drug substances and pharmaceutical products is an emerging topic in pharmaceutical quality control. GIs are intermediates or reactants in the synthetic pathway of a drug substance and should be monitored at ppm (?g/g drug substance) or even ppb (ng/g) levels. This is several orders of magnitude lower than in classical impurity analysis (0.05% or 500 ppm level) or in residual solvent analysis. Analytical methods for the determination of GIs include gas chromatography (GC) and liquid chromatography (LC), both often combined with mass spectrometry (MS) detection. Some typical examples of GIs trace analysis using GC and LC are presented. The potential of on-line reaction monitoring is also discussed.
Advances in Hydrophilic Interaction Liquid Chromatography for Pharmaceutical Analysis
May 2nd 2013Hydrophilic interaction liquid chromatography (HILIC) has recently become more important, particularly for the analysis of polar drugs, metabolites and biologically relevant compounds in glycomics, proteomics, metabolomics and clinical analysis. HILIC makes it possible to increase the retention of polar compounds, achieve orthogonal selectivity and increase mass spectrometry (MS) sensitivity, compared with reversed-phase liquid chromatography. This article discusses the advantages and limitations of HILIC in a variety of practical applications in the pharmaceutical industry.
"Critical to Quality" Measurements of Protein Aggregation in Biopharmaceuticals
January 15th 2013In biopharmaceutical development the stability of biological molecules in drug formulations is important. This article describes three different approaches to the measurement and quantification of aggregates in protein solutions, and highlights the range of information that each technique can provide about the sample.