The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated veterinary medicinal products (VMPs).
EFSA Guidance on the establishment of the residue definition for dietary risk assessment provides directions for determining the metabolites that require hazard identification and characterisation using scientific tools and methods ((Q)SAR), read-across, threshold of toxicological concern (TTC)) and available data in combination, and for developing an appropriate testing strategy for these compounds.
Under Regulation (EC) 1223/2009 all cosmetic ingredients must be demonstrated that they do not pose any health concerns under normal conditions of use.
E-cigarettes are products that can be used for consumption of nicotine-containing vapour via a mouth piece. Solutions of e-cigarettes usually contain a mixture of propylene glycol (PG), which increases flavour, vegetable glycerin, which increases vapour, nicotine (≤ 20 mg/mL), and flavourings.
LC method development is a challenging task, and a ever-new journey.
To move a step forward into your project, take the opportunity to learn from an experienced scientist: at the free webinars organized by ACD/Labs, James Hogbin draws upon 41 years of method-development experience to explain the distinction between separations and analytical methods, and how to plan for the latter following QbD principles.
Come migliorare la produttività nei laboratori delle aziende Life Science: tre webinar gratuiti e in lingua italiana organizzati da Biovia-Dassault Systèmes, dedicati al settore chimico, bio-farmaceutico, food e di largo consumo.
How to face the challenge of automating the search of new drug candidates? In this Success Story, Chiesi Group used a KNIME workflow, developed by S-IN, to have the result in approximatively 50,000 compounds with calculated properties over a timeframe of more than 4 years - without any problem or intervention, saving time and increasing productivity.
