Determination of the radiochemical purity of 99mTc medronate injection by thin layer chromatography on iTLC-SG: effect of medronate concentration on the value measured

Background When using iTLC‐SG thin layer chromatography plates to measure radiochemical impurities in 99mTc medronate, falsely high values were obtained for 99mTc pertechnetate impurity. Preliminary investigations indicated that the mass of 99mTc medronate applied to the plate influences the value....

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Bibliographic Details
Published in:Journal of labelled compounds & radiopharmaceuticals 2013-05, Vol.56 (5), p.301-304
Main Authors: Cunnane, Caroline M., O'Brien, Lesley M., Waight, Lynn A., Millar, Alistair M.
Format: Article
Language:English
Subjects:
99mTc Medronate
iTLC-SG
radiochemical purity
thin layer chromatography
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Summary:Background When using iTLC‐SG thin layer chromatography plates to measure radiochemical impurities in 99mTc medronate, falsely high values were obtained for 99mTc pertechnetate impurity. Preliminary investigations indicated that the mass of 99mTc medronate applied to the plate influences the value. Aim The goal of this study was to determine if the concentration of medronate influences the value obtained for 99mTc pertechnetate impurity. Experimental 99mTc medronate was prepared at two concentrations: 4 mg/mL and 0.2 mg/mL. Impurity levels were measured using three stationary phases: dried and undried iTLC‐SG and 54SFC paper. Two mobile phases were used: methyl ethyl ketone to detect 99mTc pertechnetate and sodium acetate 136 g/L to detect hydrolysed and colloidal 99mTc. Sample spot drying and volume were also investigated. Results With 4 mg/mL samples, the three stationary phases measured similar impurity levels (p > 0.05). With the 0.2 mg/mL samples, higher levels of 99mTc pertechnetate were measured with iTLC‐SG than with paper (p 
ISSN:0362-4803
1099-1344
DOI:10.1002/jlcr.3022