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Introduction: The aim of this study was to determine and compare the physicochemical stability of two carmustine-containing medicinal products licensed and marketed in Europe as Carmustin Obvius (Medac GmbH) and Carmubris (Tillomed Pharma GmbH). Reconstituted stock solutions and diluted ready-to-administer infusion solutions of the two products were investigated., Methods: Reconstituted carmustine stock solutions (3.3 mg/mL) and ready-to-administer infusion solutions (0.2 mg/mL, 1.0 mg/mL) prepared in prefilled 5% glucose injection solution PP/PE bags were stored at 22°C or 2-8°C over a maximum period of 66 hours protected from light. Samples were taken immediately after reconstitution or dilution and after 3.5, 6, 8.5 and 11 hours when stored at 22°C or after (12), 24, 48 and 60 hours when stored at 2-8°C, followed by 3- and 6-hour storage at 22°C (60+3 hours, 60+6 hours). Physicochemical stability was determined by reversed-phase high-performance liquid chromatography with UV detection, measurement of pH, osmolarity and inspection for visible particles or colour changes., Results: Carmustin Obvius and Carmubris reconstituted stock solutions were physicochemically stable for at least 48 hours when stored at 2-8°C. Carmustin Obvius and Carmubris infusion solutions 0.2 mg/mL were physicochemically stable for at least 8.5 hours and 60 hours when stored at 22°C and 2-8°C, respectively. After subsequent storage of the 60-hour refrigerated test solutions for 3 hours at 22°C, the carmustine concentrations averaged the 90% limit and fell below the 90% limit after 6 hours. Carmustin Obvius infusion solutions 1.0 mg/mL were physicochemically stable for at least 8.5 hours when stored at 22°C and for 60 hours when stored at 2-8°C., Conclusion: According to the physicochemical stability data, the shelf life (95% limit) of the refrigerated stock solutions is 48 hours and the shelf life (90% limit) of ready-to-administer infusion solutions (0.2 mg/mL, 1.0 mg/mL) is 60 hours at 2-8°C or 8.5 hours at 22°C under light protection. These results facilitate the use of both medicinal products in a pharmacy-based centralised cytotoxic preparation unit., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

A comparison study of different extraction and clean-up procedures for the liquid chromatographic analysis of fumonisins B(1) (FB(1)) and B(2) (FB(2)) in corn masa flour was performed. The procedures included extraction (heat or room temperature) with acidic conditions or EDTA-containing solvents, and clean-up by immunoaffinity or C18 solid-phase extraction columns. Thereafter an analytical method was optimised using extraction with an acidic mixture of methanol-acetonitrile-citrate/phosphate buffer, clean-up through the immunoaffinity column and determination of fumonisins by liquid chromatography with automated pre-column derivatisation with o-phthaldialdehyde reagent. Recovery experiments performed on yellow, white and blue masa flours at spiking levels of 400, 800 and 1200 µg kg(-1) FB(1) and of 100, 200 and 300 µg kg(-1) FB(2) gave overall mean recoveries of 99% (±6%) for FB(1) and 88% (±6%) for FB(2). Good recoveries (higher than 90% for both FB(1) and FB(2)) were also obtained with corn tortilla chips. The limits of quantification of the method (signal-to-noise ratio of 10) were 25 µg kg(-1) for FB(1) and 17 µg kg(-1) for FB(2). The method was tested on different commercial corn masa flours as well as on white and yellow corn tortilla chips, showing fumonisin contamination levels (FB(1) + FB(2)) up to 1800 µg kg(-1) (FB(1) + FB(2)) in masa flour and 960 µg kg(-1) in tortilla chips. Over 30% of masa flours originating from Mexico exceeded the European Union maximum permitted level.

A rapid, simple and sensitive multi-residue method was developed and validated for the simultaneous quantification and confirmation of 69 pesticides in fruit and vegetables using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The samples were extracted following the quick, easy, cheap, effective, rugged and safe method known as QuEChERS. Mass spectrometric conditions were individually optimised for each analyte in order to achieve maximum sensitivity in multiple reaction monitoring (MRM) mode. Using the developed chromatographic conditions, 69 pesticides can be separated in less than 17 min. Two selected reaction monitoring (SRM) assays were used for each pesticide to obtain simultaneous quantification and identification in one run. With this method in SRM mode, more than 150 pesticides can be analysed and quantified, but their confirmation is not possible in all cases according to the European regulations on pesticide residues. Nine common representative matrices (zucchini, melon, cucumber, watermelon, tomato, garlic, eggplant, lettuce and pepper) were selected to investigate the effect of different matrices on recovery and precision. Mean recoveries ranged from 70% to 120%, with relative standard deviations (RSDs) lower than 20% for all the pesticides. The proposed method was applied to the analysis of more than 2000 vegetable samples from the extensive greenhouse cultivation in the province of Almeria, Spain, during one year. The methodology combines the advantages of both QuEChERS and LC-MS/MS producing a very rapid, sensitive, accurate and reliable procedure that can be applied in routine analytical laboratories. The method was validated and accredited according to UNE-EN-ISO/IEC 17025:2005 international standard (accreditation number 278/LE1027).