A simple high-performance liquid chromatographic method, suitable for routine profiling of impurities in illegally produced amphetamine, has been developed. Amphetamine is dissolved in acetonitrile-citrate buffer (pH 3) (2:8) and injected directly without further sample pre-treatment. The impurities are enriched on-line on a C8 extraction column, while amphetamine and polar diluents are washed out with water. After washing for 1.5 min, a six-port valve is switched and an acetonitrile-0.2 M butylamine in water (pH 8) gradient elutes the impurities from the extraction column on to a C18 analytical column where they are separated. The compounds are monitored by UV detection at 220 and 254 nm. The total extraction and analysis time is 30 min. The method allows automated extraction and analysis to be performed.
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http://dx.doi.org/10.1016/s0021-9673(00)90143-2 | DOI Listing |
Pharmaceutics
December 2024
Gennova Biopharmaceuticals Ltd., ITBT Park, Hinjawadi Phase 2 Rd, Hinjewadi Rajiv Gandhi Infotech Park, Hinjawadi, Pune 411057, India.
: The nucleic acid-based product (NAP) portfolio is expanding continuously and provides safer curative options for many disease indications. Nucleic acid-based products offer several advantages compared to proteins and virus-based products. They represent an emerging field; thus, their quality control and regulatory landscape is evolving to ensure adequate quality and safety.
View Article and Find Full Text PDFProfiles Drug Subst Excip Relat Methodol
January 2025
Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh, Kingdom of Saudi Arabia. Electronic address:
Nateglinide belongs to the meglitinide class of insulin secretagogues. It is used as an oral hypoglycemic agent for the treatment of type 2 diabetes mellitus. Nateglinide is an amino acid derivative of D-phenylalanine that binds to the ATP-sensitive potassium channels in pancreatic beta cells and stimulates the secretion of insulin.
View Article and Find Full Text PDFWater Res
January 2025
Department of Civil and Environmental Engineering, University of Florence, Via di S. Marta, 3, 50139, Firenze, Italy.
The performance of Upflow Anaerobic Sludge Blanket (UASB) bioreactors treating sulfate (SO) -rich effluents depends on multiple factors, including microbial interactions and operational conditions. The high complexity of these systems necessitates the use of mathematical modelling tools to better understand the process and predict the long-term impacts of various operational variables. In this work, a mathematical model describing the long-term operation of a sulfate-fed 2.
View Article and Find Full Text PDFNaunyn Schmiedebergs Arch Pharmacol
January 2025
Department of Toxicology, Faculty of Pharmacy, Yeditepe University, 34755, Ataşehir, Istanbul, Turkey.
Establishing the safety of impurities in drug substances or products is crucial. The assessment of genotoxicity for these impurities and determining the acceptable limits pose considerable challenges, as recognized in recent guidelines. While the genotoxicity profile of vildagliptin-an oral hypoglycemic drug-is well established, there is limited knowledge about the genotoxic potential of its impurities.
View Article and Find Full Text PDFBiotechnol J
January 2025
Biologics Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA.
Chinese hamster ovary (CHO) cells are widely used to produce recombinant proteins, including monoclonal antibodies (mAbs), through various process modes. While fed-batch (FB) processes have been the standard, a shift toward high-density perfusion processes is being driven by increased productivity, flexible facility footprints, and lower costs. Ensuring the clearance of process-related impurities, such as host cell proteins (HCPs), is crucial in biologics manufacturing.
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