3PC-009 Physicochemical stability of intravenous injection of a generic product of furosemide prepared in polypropylene syringes

BackgroundFurosemide is a diuretic widely indicated in paediatric diseases especially for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver or renal disease. Its stability is very important and must be proved to ensure paediatric patient safety.PurposeThe aim of this study was to determine the physicochemical stability for furosemide 1 mg/ml in polypropylene syringes stored in different conditions.Material and methodsNine polypropylene syringes were prepared using the generic product of furosemide (1 mg/ml) in NaCl 0.9%. The nine syringes were stored in different conditions for 72 hours. The following table describes these conditions:Abstract 3PC-009 Table 1Number of syringes of furosemide 1 mg/ml 3 3 3 Temperature25°C±3°C 8°C±3°C 25°C±3°C LightDaylight Absent Artificial We studied several physical and chemical parameters immediately after preparation (0 hour) and after 6, 24, 48 and 72 hours. These parameters are colour, opacity, presence of precipitation or microagregate, pH and absorbance.Each preparation was visually inspected in front of a black and white background. Preparations were centrifuged and aliquots were examined by microscope. pH measurements were carried out by pH-metre and spectrophotometric measurements were obtained after dilution of solutions, at three wavelengths: 229, 278 and 331 nm with a UV-visible spectrophotometer.ResultsAfter 72 hours, no colour change, no opacity, no precipitation and no microaggregate were observed. For chemical parameters, there was no variation in pH absorbance in all conditions of storage.For spectrophotometric measurements, there is no significant change in absorbance in all conditions of storage. Studies showed that degradation products do not absorb at the same wavelengths of furosemide. We can deduce that the method used is specific for the determination of furosemide.ConclusionFurosemide 1 mg/ml in NaCl 0.9% propylene syringes preserved its physical and chemical properties for at least 72 hours in all conditions of storage. So we can prepare many paediatric injections in our hospital that we can store for 72 hours.References and/or Acknowledgements1. HansBundgaard, et al. Photodegradation and hydrolysis of furosemide and furosemide esters in aqueous solutions. Int J Pharma, 1988; 42: 217–224.No conflict of interest