Implementation of Analytical Control of Low Volume Pediatric Cytotoxic Drugs Preparations using a UV/Raman Spectrophotometer

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.