Simplified method for determining the radiochemical purity of 99mTc-MAG3.
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.


CONCLUSIONS
The simplified method is a reasonable alternative to the registered SPC methods.
Seetharaman
Shankar
S
Pharmaceutical Quality Assurance, Guy's and St. Thomas' Hospital, London, and Department of Pharmacy and Biomolecular Sciences, University of Brighton, Moulscoomb, United Kingdom.
Ballinger
James R
JR
Sosabowski
Michael H
MH
D011785:Quality Assurance, Health Care / Q000379:methods* / Q000592:standards*; D019275:Radiopharmaceuticals / Q000032:analysis / Q000592:standards; D052616:Solid Phase Extraction / Q000379:methods* / Q000592:standards*; D017263:Technetium Tc 99m Mertiatide / Q000032:analysis* / Q000737:chemistry / Q000592:standards*; D013997:Time Factors; D006113:United Kingdom
D019275:Radiopharmaceuticals; D017263:Technetium Tc 99m Mertiatide