Rationale: Cytotoxic drug preparation in hospital pharmacies is associated with chronic occupational exposure leading to a risk of adverse effects. The objective was to develop and validate a quantification method for the following cytotoxic drugs in environmental wipe samples: cyclophosphamide, ifosfamide, cytarabine, dacarbazine, docetaxel, paclitaxel, doxorubicin, epirubicin, etoposide, 5-fluorouracil, gemcitabine, irinotecan, methotrexate and pemetrexed. Methods:The quantification method was developed using liquid chromatography coupled to tandem mass spectrometry and a wiping technique using viscose swabs.Linearity, accuracy, precision, limit of quantification, specificity and stability were assessed, from swab desorbed solution, to validate the analytical method, with respect to ICH guidelines. Environmental samples were collected by wiping five work surfaces of 225 cm 2 with viscose swabs, during three days. Results:The quantification method was linear over the calibration range with a lower limit of quantification ranging from 0.5 to 5.0 ng mL −1 depending on the cytotoxic drug. The intra-day and inter-day relative biases were below 1.5% and 13.5%, respectively. This method was successfully applied to surface-wipe sampling and environmental contaminations ranged from 0.7 to 1840.0 ng cm −2 for the most contaminated areas. Conclusions:This quantification method for 14 cytotoxic drugs was successfully applied to environmental contamination monitoring and could therefore be a useful tool for monitoring and toxicological studies.

Abstract: Pediatric chemotherapy preparations are usually not analytically controlled, for several reasons. First, they are generally made in syringe, which does not allow to take a sample without changing the final volume. Secondly, the percentage of the dose consecrated to control is important and finally low concentrations can cause sensitivity problems. This lack of quality control, greatly reduces the security of the chemotherapy circuit.: The main objective is to develop an analytical control to low volume pediatric preparations, made in syringes or in infusion bags with a final volume from 20 to 50 mL.: The development of analytical control automatons, like QCPrep+: Our protocol implies the overfilling with one milliliter of solvent followed by a sampling of one milliliter. The analysis is performed with 900 µL. Ten cytotoxic drugs commonly used in pediatric oncology have been validated according to ICH recommendations. The development of analytical control for low volume preparations allows young patients to benefit the same level of safety and quality than adult patients.

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