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Published on: February 4, 2017
Simplified method for determining the radiochemical purity of 99mTc-MAG3
Shankar Seetharaman1, James R Ballinger, Michael H Sosabowski
1Pharmaceutical Quality Assurance, Guy's and St. Thomas' Hospital, London, and Department of Pharmacy and Biomolecular Sciences, University of Brighton, Moulscoomb, United Kingdom.
Unlabelled:
99mTc-Mercaptoacetyltriglycine is used for dynamic renal imaging, and the summary of product characteristics (SPC) for the European formulation specifies a shelf life of 1 or 4 h, depending on the reconstitution volume of the kit. To minimize the time required to test the radiochemical purity, a simplified quality control method was developed.
Methods:
To satisfy the recommendations of the International Commission on Harmonisation, results obtained with the methods described in the European and American SPCs were compared with those obtained with the simplified method. Further validation of the new method was performed by comparison with the standard 2-strip thin-layer chromatographic method as well as tests for linearity and limits of detection and quantification.
Results:
The simplified method provided results comparable to those provided by the registered SPC methods but was more rapid to perform and used smaller volumes of solvents.
Conclusion:
The simplified method is a reasonable alternative to the registered SPC methods.
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