Validation of an alternative radiochemical purity method for [99mTc]pentetate ([99mTc]DTPA)

Appl Radiat Isot. 2013 Dec:82:322-4. doi: 10.1016/j.apradiso.2013.09.007. Epub 2013 Oct 3.

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.

Keywords: (99m)Tc; DTPA; ITLC; Pentetate; Radiochemical purity; Validation.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Butanones
  • Chromatography, Paper / methods
  • Chromatography, Paper / standards
  • Chromatography, Thin Layer / methods
  • Chromatography, Thin Layer / standards
  • Drug Stability
  • Humans
  • Quality Control
  • Radioisotope Renography
  • Radiopharmaceuticals / standards*
  • Technetium Tc 99m Pentetate / standards*

Substances

  • Butanones
  • Radiopharmaceuticals
  • methylethyl ketone
  • Technetium Tc 99m Pentetate