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9430285 
Journal Article 
Epirubicin stability in syringes and glass vials and evaluation of chemical contamination 
Walker, SE; Lau, DWC; Deangelis, C; Iazzetta, J; Coons, C 
1990 
Yes 
Canadian Journal of Hospital Pharmacy
ISSN: 0008-4123 
43 
6 
265-272 
English 
The concentration of reconstituted epirubicin hydrochloride solution (2 mg/mL) was evaluated during 150 days storage in original manufacturers vials and two different brands of syringes (Terumo, Monoject) at 4°C and 23°C. On each of the 15 study days the epirubicin hydrochloride concentration was determined using a validated, stability-indicating liquid chromatographic method. On each day pH, colour and physical inspection and evaluation of the concentration of 2-mercaptobenzothiazole (MBT) and 2-(2-hydroxyethylmercapto) benzothiazole (HMBT) and 2-ethylhexylphthalate (DEHP) were also measured. During the 150-day study period all solutions stored at 4°C and 23°C retained more than 90 percent of the initial epirubicin hydrochloride concentration, remained clear and had no change in UV-VIS spectrum absorbance or pH. On day 150, mass balance indicated that approximately two percent of the epirubicin had degraded to degradation products and no leachable compounds could be detected. We conclude that epirubicin solutions (1 mg/mL and 2 mg/mL) stored at 4°C or 23°C in the original glass vial are stable for 150 days. Since investigations have failed to demonstrate contamination of these solutions stored in Terumo or Monoject syringes, we conclude that epirubicin solutions are stable when stored at 4°C or 23°C in syringes, and maintain acceptable product purity. 
epirubicin; article; drug stability; liquid chromatography; storage