title: Stability of thiotepa (lyophilized) in 5% dextrose injection at 4 and 23 degrees C.
abstract: The stability of thiotepa (lyophilized) 0.5 and 5 mg/mL in 5% dextrose injection was studied. Vials of lyophilized thiotepa were reconstituted with sterile water for injection to yield a solution with a nominal 10-mg/mL drug concentration. The reconstituted solution was filtered and diluted in 5% dextrose injection in polyvinyl chloride and polyolefin bags to nominal thiotepa concentrations of 0.5 and 5 mg/mL. Triplicate test admixtures were prepared and stored at 4 or 23 degrees C in normal fluorescent light. Initially and after four and eight hours and 1, 3, 7, and 14 days, samples were removed for visual evaluation, turbidimetry, and stability-indicating high-performance liquid chromatography. No incompatibilities were observed. Admixtures containing thiotepa 0.5 mg/mL retained at least 90% of the initial drug concentration for eight hours at either temperature in either type of container; after 24 hours, losses ranged from 10% to 17%. Thiotepa in the 5-mg/mL admixtures was stable for 3 days at 23 degrees C and 14 days at 4 degrees C in both container types. Thiotepa (lyophilized) 0.5 mg/mL in 5% dextrose injection was stable for eight hours at 4 or 23 degrees C. Thiotepa (lyophilized) 5 mg/mL in 5% dextrose injection was stable for 3 days at 23 degrees C and 14 days at 4 degrees C.
authors.affiliation: Pharmaceutical Analysis Laboratory, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
authors.forename: Q A
authors.initials: QA
authors.lastname: Xu
authors.forename: L A
authors.initials: LA
authors.lastname: Trissel
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.forename: J F
authors.initials: JF
authors.lastname: Martinez
authors.forename: D L
authors.initials: DL
authors.lastname: Gilbert
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000737:chemistry*; D011232:Chemical Precipitation; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D005947:Glucose / Q000008:administration & dosage; D007262:Infusions, Intravenous; D009391:Nephelometry and Turbidimetry; D010969:Plastics; D011090:Polyenes; D011143:Polyvinyl Chloride; D013852:Thiotepa / Q000737:chemistry*
chemical_list: D018906:Antineoplastic Agents, Alkylating; D010969:Plastics; D011090:Polyenes; C035051:PL 732; D011143:Polyvinyl Chloride; D013852:Thiotepa; D005947:Glucose