RT Journal Article SR Electronic T1 The Influence of Formulation Excipients on the Stability of the Novel Antitumor Agent Carzelesin (U-80,244) JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 283 OP 288 VO 49 IS 6 A1 Vries, Jantine D. Jonkman-De A1 Rosing, Hilde A1 Henrar, Roland E. C. A1 Bult, Auke A1 Beijnen, Jos H. YR 1995 UL http://journal.pda.org/content/49/6/283.abstract AB The stability of carzelesin in a polyethylene glycol 400 (PEG 400)/absolute ethanol/polysorbate 80 (Tween 80) (6:3:1, v/v/v) formulation (PET formulation) was investigated as a function of the inter-batch variability of the three excipients. Twenty different PET formulations were tested and the stability of carzelesin in the PET formulation was found to be influenced by the type of PEG 400 used. Subsequent investigations showed that the pH of PEG 400, and consequently the pH of the PET formulation, was responsible for the variable stability characteristics of carzelesin in the PET formulation. The higher the pH of the PET formulation, the higher the rate of degradation of carzelesin in PET. The major degradation products were found to be U-76,073 and U-76,074.