STABILITY OF DOXORUBICIN, DAUNORUBICIN and EPIRUBICIN IN PLASTIC SYRINGES and MINIBAGS

Abstract

The shelf lives of doxorubicin, daunorubicin and epirubicin in infusion fluids were studied using high-performance liquid chromatographic (HPLC) methods. Doxorubicin and epirubicin were stable (loss in potency of less than 10%) for 24 and 20 days respectively, when dissolved in sodium chloride solution (0.9%; pH, 6.47) at 25 degrees C and stored in polyvinyl chloride (PVC) minibags, while daunorubicin was stable for at least 43 days. All three drugs were stable for at least 43 days in sodium chloride (0.9%; pH 6.47 and 5.20) and dextrose (5%; pH 4.36) at 4 and -20 degrees C. Repeated thawing and re-freezing of these solutions at ambient temperature did not cause degradation. All three drugs were stable for at least 43 days when reconstituted with Water-for-Injections BP and stored in polypropylene syringes at 4 degrees C.