Stability of refrigerated and frozen solutions of doxorubicin hydrochloride

The stability of refrigerated and frozen solutions of doxorubicin hydrochloride was studied. Vials of doxorubicin hydrochloride with lactose (Adriamycin) were reconstituted with Sterile Water for Injection, USP, to provide a drug concentration of 2 mg/ml. Samples were refrigerated (4 C) for up to one year and frozen (-20C) for 30 days then assayed by high-performance liquid chromatography. One sample was assayed then refrozen each test period. Refrigerated and frozen samples showed no substantial loss of potency after six months and one month of storage, respectively. Filtration through a 0.22-micron filter did not affect potency. Degradation products were not detected, except for an unidentified small peak detected in the sample refrigerated for one year. Doxorubicin hydrochloride, when reconstituted with sterile water for injection, may be refrigerated for six months or frozen for one month without loss of potency.