Comprehensive online multicolumn two-dimensional liquid chromatography-diode array detection-mass spectrometry workflow as a framework for chromatographic screening and analysis of new drug substances
Sign Up to like & getrecommendations! Published in 2020 at "Analytical and Bioanalytical Chemistry"
DOI: 10.1007/s00216-020-02498-8
Abstract: The analysis of complex mixtures of closely related species is quickly becoming a bottleneck in the development of new drug substances, reflecting the ever-increasing complexity of both fundamental biology and the therapeutics used to treat… read more here.
Keywords: chromatography; analysis; new drug; drug substances ... See more keywords
Development and validation of a sensitive method for alkyl sulfonate genotoxic impurities determination in drug substances using gas chromatography coupled to triple quadrupole mass spectrometry
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Pharmaceutical and Biomedical Analysis"
DOI: 10.1016/j.jpba.2018.12.044
Abstract: HighlightsQuantitative detection of 9 sulfonate esters by GC–MS‐MS simultaneously.The method gave extremely high sensitivity for 9 sulfonate esters compared to reported articles.LOQs for 9 sulfonate esters were within 0.10–1.05 ng mL−1.This method was successfully applied… read more here.
Keywords: alkyl; drug substances; method; drug ... See more keywords
European fingerprint study on omeprazole drug substances using a multi analytical approach and chemometrics as a tool for the discrimination of manufacturing sources.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2021.114444
Abstract: Like drug products, Active Pharmaceutical Ingredients (APIs) are subject to substandard and falsification issues, which represent a threat to patient health. In order to monitor the quality of drug substances and prevent the use of… read more here.
Keywords: study omeprazole; drug substances; drug; manufacturing sources ... See more keywords
Pharmaceutical Cocrystal: An Antique and Multifaceted Approach.
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DOI: 10.2174/1567201813666161018152411
Abstract: BACKGROUND Pharmaceutical cocrystal is an emerging approach to tailor physicochemical and mechanical properties of drug substances. Cocrystals are composed of API and pharmaceutically acceptable coformer. It is used to address the solubility, dissolution, mechanical properties… read more here.
Keywords: drug substances; drug; mechanical properties; cocrystal antique ... See more keywords
Distribution of Drug Substances in Solid Lipid Microparticles (SLM)—Methods of Analysis and Interpretation
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DOI: 10.3390/pharmaceutics14020335
Abstract: The incorporation of drug substances into the matrix of solid lipid microparticles (SLM) is critical to providing effects such as prolonged release, taste masking, and protection of the labile API. Currently, a commonly used method… read more here.
Keywords: lipid matrix; drug substances; drug; method ... See more keywords
A substructure-based screening approach to uncover N-nitrosamines in drug substances
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Food and Drug Analysis"
DOI: 10.38212/2224-6614.3400
Abstract: Drug substances are at risk of contamination with N-nitrosamines (NAs), well-known carcinogenic agents, during synthesis processes and/or long-term storage. Therefore, in this study, we developed an efficient data-based screening approach to systemically assess marketed products… read more here.
Keywords: drug substances; screening approach; based screening; substructure based ... See more keywords