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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Borré, María Candela Tesán, Fiorella C. Leonardi, Natalia M. Zubillaga, Marcela B. Salgueiro, M. Jimena |
| Description | Author Affiliation: Borré MC ( 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.) |
| 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. |
| File Format | HTM / HTML |
| ISSN | 09698043 |
| Volume Number | 82 |
| e-ISSN | 18729800 |
| Journal | Applied Radiation and Isotopes |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2013-12-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Nuclear Medicine Radiopharmaceuticals Standards Technetium Tc 99m Pentetate Butanones Chromatography, Paper Methods Chromatography, Thin Layer Drug Stability Humans Quality Control Radioisotope Renography Journal Article Research Support, Non-u.s. Gov't Validation Studies |
| Content Type | Text |
| Resource Type | Article |
| Subject | Radiation |
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