Shelf lives of aseptically prepared medicines--stability of piperacillin/tazobactam in PVC and non-PVC bags.

Parenteral aseptic preparations of piperacillin/tazobactam are used frequently in hospitals, but there is limited published information on their stability in polyvinyl chloride (PVC) and polyolefine laminate (non-PVC). The purpose of this study was to evaluate the stability in these containers and to determine the optimum validated shelf life so that the formulations may be prepared in bulk in appropriately licensed facilities. In the first study, the stability of piperacillin/tazobactam 45 mg/ml was determined in polyvinyl chloride and polyolefine laminate bags in 0.9% (w/v) sodium chloride at 7 degrees C, 25 degrees C/60% relative humidity (RH) and room temperature in the light (RTL) with storage up to 41 days for PVC bags and 98 days for non-PVC bags. In the second study, the stability of piperacillin/tazobactam 45 mg/ml was determined in non-PVC bags in a buffered sodium chloride formulation at 7 degrees C, 25 degrees C/60% RH and RTL with storage up to 201 days. Samples from each admixture were analysed for piperacillin concentration, tazobactam concentration and appearance of decomposition products by stability indicating high-performance liquid chromatography (HPLC). The pH and appearance of solution and container were also monitored. Shelf lives were calculated using the maximum rate method. Tazocin was found to be stable in 0.9% (w/v) sodium chloride in PVC bags for up to 5 days at 7 degrees C and 4 days at both 25 degrees C and RTL. In non-PVC bags, it was stable for 17, 4 and 3 days, respectively. It was stable in the buffered sodium chloride formulation in non-PVC bags for up to 58 days at 7 degrees C, 10 days at 25 degrees C and 7 days at RTL.

Shelf lives of aseptically prepared medicines--stability of hydrocortisone sodium succinate in PVC and non-PVC bags and in polypropylene syringes.

Parenteral aseptic preparations of hydrocortisone sodium succinate (HSS) are used frequently in hospitals, but little definitive stability information is available. The purpose of this study was to obtain ultimate shelf lives for typical formulations so that they may be prepared in bulk in appropriately licensed facilities. In the first study, the stability of HSS, 1mg/ml, was determined in polyvinyl chloride (PVC) bags and polyolefine (non-PVC) bags, in 0.9% (w/v) sodium chloride at 7 degrees C, 25 degrees C/60% relative humidity (RH) and room temperature in the light (RTL) with storage for up to 135 days. In the second study, the stability of HSS, 50 mg/ml was determined in polypropylene syringes at 5 degrees C and 25 degrees C/60%RH with storage for up to 120 days. Samples from each admixture were analysed by stability indicating high performance liquid chromatography (HPLC) and were monitored for pH, appearance of solution and container, and the rate of appearance of decomposition products. Shelf lives were calculated using the maximum rate method. HSS at a concentration of 1 mg/ml in PVC bags was stable for up to 41 days at 7 degrees C, 8 days at 25 degrees C and 7 days at RTL. It was stable in non-PVC bags for up to 48, 8 and 6 days, respectively. HSS in polypropylene syringes at a strength of 50 mg/ml was stable for up to 81 days at 5 degrees C and 6 days at 25 degrees C.

Shelf lives of aseptically prepared medicines--stability of netilmicin injection in polypropylene syringes.

There is no published information on the stability of netilmicin solutions in prefilled syringes. The purpose of this study was to evaluate the stability of netilmicin in polypropylene syringes and to determine the optimum validated shelf life so that they may be prepared in bulk in appropriately licensed facilities. The syringes containing netilmicin 10 or 100mg/ml were stored at 7 degrees C, room temperature in the light (RTL) and 25 degrees C/60% relative humidity for up to 300 days. Netilmicin concentration was determined by reversed phase high performance liquid chromatography (RP-HPLC) of the isoindole derivative formed with o-phthalaldehyde (OPA). The shelf lives were calculated using the maximum rate method applied to the netilmicin analytical data. At 7 degrees C 10 and 100mg/ml solutions were stable for 90 days falling to 30 days at 25 degrees C and 60% RH. At RTL the 10mg/ml solution was stable for 9 days.