Non-ionic surfactants are commonly used in parenteral protein formulations and include polysorbate 20, polysorbate 80 and poloxamer188. Recently, quantification and characterization of surfactants has generated considerable interest due to their connection to visible particle formation, a critical quality attribute for parenteral formulations. Typically, surfactant quantification is performed by mixed mode chromatography with evaporative light scattering detection (ELSD) or charged aerosol detection (CAD). However, these methods often suffer from loss of specificity in highly concentrated protein formulations. Here we present a mixed mode chromatography method using single quad mass detection, overcoming current limitations for highly concentrated proteins. In addition to content determination of intact surfactants, this method allows to quantify and characterize the predominant degradation patterns of polysorbates within a single measurement. Formulations with up to 200 mg/mL active pharmaceutical product (API) containing surfactant levels between 0.16 and 0.64 mg/mL were tested during method qualification. The obtained results for linearity (r > 0.99), precision (max. 3.8 % RSD) and accuracy (96-116 % recovery) meet current requirements for pharmaceutical products as defined in ICH Q2.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/j.jpba.2023.115651 | DOI Listing |
J Strength Cond Res
December 2024
Jayhawk Athletic Performance Laboratory, Wu Tsai Human Performance Alliance, University of Kansas, Lawrence, Kansas.
Eserhaut, DA, DeLeo, JM, and Fry, AC. Blood flow restricted resistance exercise in well-trained men: Salivary biomarker responses and oxygen saturation kinetics. J Strength Cond Res 38(12): e716-e726, 2024-Resistance exercise with continuous lower-limb blood flow restriction (BFR) may provide supplementary benefit to highly resistance-trained men.
View Article and Find Full Text PDFPLoS One
January 2025
Department of Sociology, The Ohio State University, Columbus, Ohio, United States of America.
Research over the past two decades has noted significant racial/ethnic wealth inequalities-inequalities with important implications for life chances and institutional access. Home ownership is as a foundational element of such inequality with broad consequences for exposure to crime, quality of public safety services, and access to healthcare, education, and employment. Building on earlier scholarship that has tended to focus on specific forms of mortgages, we draw in this article on over 1.
View Article and Find Full Text PDFAppl Biochem Biotechnol
January 2025
Department of Internal Medicine-Cardiovascular, Guangzhou Twelfth People's Hospital, No.1, Tianqiang Road, Tianhe District, Guangzhou City, Guangdong Province, 510620, China.
Myocardial infarction (MI) is a coronary artery-related disease that seriously threatens human life and is the leading cause of sudden death worldwide, where a lack of nutrients and oxygen leads to an inflammatory response and death of cardiomyocytes. Ferroptosis is a form of non-apoptotic cell death associated with metabolic dysfunction, resulting in abnormal breakdown of glutamine and iron-dependent accumulation of reactive oxygen species (ROS) during metabolism. However, the molecular mechanism of ferroptosis in the pathogenesis of MI and the function of Klotho and KRAS on ferroptosis during MI remain unclear.
View Article and Find Full Text PDFMikrochim Acta
January 2025
Institute of Chemical Engineering, Guangdong Academy of Sciences, Guangzhou, 510665, People's Republic of China.
A simple and rapid colorimetric detection strategy, based on hydrogen bond identification of 6-thioguanine (6-TG) functionalized Au nanoparticles (AuNPs), is proposed for highly selective and sensitive determination of kanamycin (KA). In this strategy, the hydrogen bond interaction between 6-TG and kanamycin induces AuNPs to agglomerate, with a consequent color change of AuNPs from wine red to purple or even blue. The kanamycin concentrations can be quantified by employing UV-vis spectrophotometer.
View Article and Find Full Text PDFAnalyst
January 2025
Department of Engineering and Architecture, University of Trieste, via A. Valerio 6, 34127 Trieste, Italy.
Ergothioneine (ERG) is a natural sulfur-containing amino acid found in many organisms, including humans. It accumulates at high concentrations in red blood cells and is distributed to various organs, including the brain. ERG has numerous health benefits and antioxidant capabilities, and it has been linked to various human physiological processes, such as anti-inflammatory, neuroprotective, and anti-aging effects.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!