title: Validation of an alternative radiochemical purity method for [99mTc]pentetate ([99mTc]DTPA).
abstract: [(99m)Tc]pentetate ([(99m)Tc]DTPA) is the most commonly used radiopharmaceutical renography agent. The aim of this work was to validate an alternative method for assessing [(99m)Tc]DTPA radiochemical purity (RCP), according to the ICH Q2(R1) guidance: "Validation of Analytical Procedures". The proposed method is composed of two chromatographic systems. System A is a miniaturized system of thin layer chromatography (TLC) silica gel impregnated aluminum strips as stationary phase (SP) and distilled water as mobile phase (MP). System B consists of Whatman 1 paper strips as SP and methyl ethyl ketone as MP. Results indicate that the proposed RCP method has been validated, as it is specific, precise, accurate, linear and robust. Therefore, it can be used as an alternative method for RCP quality control purposes and as stability indicator as well.
authors.affiliation: Radioisotope Laboratory, Physics Department, School of Pharmacy and Biochemistry, University of Buenos Aires, Junín 956 PB, Buenos Aires (C1113AAD), Argentina. Electronic address: candelaborre@hotmail.com.
authors.forename: María Candela
authors.initials: MC
authors.lastname: Borré
authors.forename: Fiorella C
authors.initials: FC
authors.lastname: Tesán
authors.forename: Natalia M
authors.initials: NM
authors.lastname: Leonardi
authors.forename: Marcela B
authors.initials: MB
authors.lastname: Zubillaga
authors.forename: M Jimena
authors.initials: MJ
authors.lastname: Salgueiro
mesh_terms: D002074:Butanones; D002854:Chromatography, Paper / Q000379:methods / Q000592:standards; D002855:Chromatography, Thin Layer / Q000379:methods / Q000592:standards; D004355:Drug Stability; D006801:Humans; D011786:Quality Control; D011866:Radioisotope Renography; D019275:Radiopharmaceuticals / Q000592:standards*; D016284:Technetium Tc 99m Pentetate / Q000592:standards*
chemical_list: D002074:Butanones; D019275:Radiopharmaceuticals; C005222:methylethyl ketone; D016284:Technetium Tc 99m Pentetate
keywords: (99m)Tc; DTPA; ITLC; Pentetate; Radiochemical purity; Validation