title: Formulation, quality control and shelf life of the experimental cytostatic drug cyclopentenyl cytosine.
abstract: This paper describes the formulation and quality control of an aqueous sterilized formulation of the experimental cytostatic drug cyclopentenyl cytosine (CPEC) to be used in Phase I/II clinical trials. The raw drug substance was extensively tested. A High Pressure Liquid Chromotography (HPLC) method was validated for the quality control of the formulated product. The aqueous formulation was found to be stable for at least 2 years at 2-8 degrees C. Sterilization (15 min at 121 degrees C) showed no influence on drug stability. The results show that CPEC can be formulated in an aqueous solution. The described HPLC method is a useful tool in the pharmaceutical quality control.
authors.affiliation: Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands. k.j.m.schimmel@lumc.nl
authors.forename: Kirsten
authors.initials: K
authors.lastname: Schimmel
authors.forename: Henk-Jan
authors.initials: HJ
authors.lastname: Guchelaar
authors.forename: Erik
authors.initials: E
authors.lastname: van Kan
mesh_terms: D000970:Antineoplastic Agents / Q000737:chemistry / Q000592:standards; D002626:Chemistry, Pharmaceutical; D003562:Cytidine / Q000031:analogs & derivatives* / Q000737:chemistry / Q000592:standards; D004355:Drug Stability; D004356:Drug Storage; D015507:Drugs, Investigational / Q000737:chemistry / Q000592:standards; D015394:Molecular Structure; D011786:Quality Control
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational; D003562:Cytidine; C045911:cyclopentenyl cytosine