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Solubility is an important physicochemical parameter in nanoregulation. If nanomaterial is completely soluble, then from a risk assessment point of view, its disposal can be treated much in the same way as "ordinary" chemicals, which will simplify testing and characterisation regimes. This review assesses potential techniques for the measurement of nanomaterial solubility and evaluates the performance against a set of analytical criteria (based on satisfying the requirements as governed by the cosmetic regulation as well as the need to quantify the concentration of free (hydrated) ions). Our findings show that no universal method exists. A complementary approach is thus recommended, to comprise an atomic spectrometry-based method in conjunction with an electrochemical (or colorimetric) method. This article shows that although some techniques are more commonly used than others, a huge research gap remains, related with the need to ensure data reliability.
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http://dx.doi.org/10.3109/17435390.2015.1038661 | DOI Listing |
Mol Ther Methods Clin Dev
September 2025
Pfizer Inc., Analytical Research and Development, 875 Chesterfield Pkwy. West, Chesterfield, MO 63017, USA.
The multi-attribute method (MAM), a mass spectrometry technique for quantifying amino acid modifications at the peptide level, is becoming a prominent analytical tool in the development of biotherapeutics. The method has promise for adeno-associated virus (AAV) therapeutics, where capsid protein modifications have been directly linked to reduced transduction efficiency. Given this link, a robust and precise procedure to quantitate capsid modifications would be beneficial for implementation throughout biotherapeutic development.
View Article and Find Full Text PDFDiagn Microbiol Infect Dis
September 2025
French National Reference Center for Hepatitis B, C and delta Viruses, Department of Virology, Hôpital Henri Mondor, Créteil, France; INSERM U955, Créteil, France. Electronic address:
Measurement of hepatitis B virus (HBV) DNA levels is the standard of care for diagnosis active HBV infection, assessing disease severity and prognosis, and guiding treatment decisions and monitoring response to therapy. In the study, the analytical and clinical performance of the ELITe InGenius System for quantifying HBV DNA was evaluated. A total of 377 of archived EDTA plasma or serum specimens were tested.
View Article and Find Full Text PDFInt J Pharm
September 2025
Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USA. Electronic address:
Quality control of drug products is an essential step in pharmaceutical manufacturing. It is often time-consuming and requires expensive equipment. Process analytical technology tools are typically integrated into the manufacturing process to monitor quality, thereby reducing time and costs.
View Article and Find Full Text PDFCarbohydr Polym
November 2025
Department of Pharmacy - Pharmaceutical Sciences, University of Bari Aldo Moro, E. Orabona St., 70125 Bari, Italy.
Direct printing of pharmaceutical powders allows the creation of personalized paediatric dosage forms, such as orodispersible films (ODFs). In this study, we present an optimized protocol to prepare midazolam (MDZ)/γ-cyclodextrin (γ-CD) inclusion complex-loaded ODFs using the innovative direct powder extrusion 3D printing technique (DPE). ODFs were formulated with a polymer blend consisting of polyethylene oxide and hydroxypropyl methylcellulose, in the presence or without γ-CD.
View Article and Find Full Text PDFSpecific protein detection plays a crucial role in biological analysis and clinical diagnostics, serving as an essential tool for disease diagnosis, therapeutic monitoring, and biological research. However, conventional methods such as immunofixation electrophoresis (IFE) and western blotting (WB) suffer from complex workflows, time-consuming operations, and limited quantification capabilities owing to intricate staining and de-staining procedures. In addition, these traditional immunological detection methods require extensive manual handling and specialized expertise, while low levels of automation restrict their applicability to high-throughput or large-scale analysis scenarios.
View Article and Find Full Text PDF