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9430383 
Journal Article 
Doxorubicin stability in syringes and glass vials and evaluation of chemical contamination 
Walker, S; Lau, D; Deangelis, C; Iazzetta, J; Coons, C 
1991 
Yes 
Canadian Journal of Hospital Pharmacy
ISSN: 0008-4123 
44 
2 
71-78+88 
English 
The concentration of reconstituted doxorubicin hydrochloride solution (2 mg/mL) was evaluated during 124 days storage in original manufacturers vials and two different brands of syringes (Terumo, Monoject) at 4°C and 23°C. On each of 14 study days the doxorubicin hydrochloride concentration was determined using a validated, stability-indicating liquid chromatographic method. On each day pH, colour, physical inspection and the concentration of 2-mercaptobenzothiazole (MBT), 2-(2-hydroxyethylmercapto) benzothiazole (HMBT) and di-2-ethylhexylphthalate (DEHP) was also measured. During the 124-day study period all solutions stored at 4°C and 23°C retained more than 90 percent of the initial doxorubicin hydrochloride concentration, remained clear and had no change in UV-VIS spectrum absorbance or pH. On day 124, mass balance indicated that approximately 3.5 percent of the doxorubicin had degraded at room temperature and about one percent had degraded at 4°C. The MBT, HMBT and DEHP concentrations were below detectable limits. We conclude that doxorubicin solutions (2 mg/mL) stored at 4°C or 23°C in the original glass vial are stable for 124 days. Since investigations have failed to demonstrate contamination of these solutions stored in Terumo or Monoject syringes, we conclude that doxorubicin solutions (1 mg/ml and 2 mg/ml) are stable when stored at 4°C or 23°C in syringes, and maintain acceptable product purity. 
doxorubicin; glass; plasticizer; article; contamination; drug degradation; drug stability; drug storage; liquid chromatography; ph; syringe; temperature