Effect of solvent flow rate in mini-column testing of 99mTc-mertiatide.
OBJECTIVE
The recommended method for radiochemical purity testing of 99mTc-mertiatide involves the use of a C-18 solid-phase mini-column cartridge. The mertiatide package insert states that the solvents should be "pushed through the cartridge slowly," but a flow rate is not specified. The mini-column cartridge instruction sheet recommends flow rates of 5-10 and 2-10 mL/min for conditioning and for elution, respectively, of the cartridge. The purpose of this study was to evaluate the effect of different flow rates on determining the radiochemical purity of 99mTc-mertiatide.


METHODS
Radiochemical purity was tested on 10 consecutive vials of 99mTc-mertiatide prepared for routine clinical use and on 4 vials of 99mTc-mertiatide spiked with 6%-15% free pertechnetate using 3 different flow rates: slow drip (5 mL/min for conditioning and 2 mL/min for elution), fast drip (10 mL/min for conditioning and 10 mL/min for elution), and very fast drip (about 15-20 mL/min for conditioning and about 15-20 mL/min for elution). An infusion pump was used to provide constant flow rates for the first 2 conditions, whereas manual handling, reflecting real-life practice, was used for the third condition.


RESULTS
All 3 flow rates yielded essentially identical radiochemical purities for each vial tested (agreement was always within 0.3% for a given vial). The elapsed times for mini-column conditioning, loading, and elution were approximately 15, 5, and 3 min for the slow drip, fast drip, and very fast drip, respectively.


CONCLUSIONS
Faster flow rates for mini-column testing of 99mTc-mertiatide save time (and correspondingly reduce radiation exposure to the worker) without adversely affecting the results of radiochemical purity determinations.
Ponto
James A
JA
Department of Radiology, University of Iowa Hospital and University of Iowa College of Pharmacy, Iowa City, Iowa 52242, USA. james-ponto@uiowa.edu
D002853:Chromatography, Liquid / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D004353:Drug Evaluation, Preclinical / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D017022:Flow Injection Analysis / Q000379:methods; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000592:standards; D019275:Radiopharmaceuticals / Q000032:analysis / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012997:Solvents / Q000737:chemistry; D017263:Technetium Tc 99m Mertiatide / Q000032:analysis* / Q000592:standards
D019275:Radiopharmaceuticals; D012997:Solvents; D017263:Technetium Tc 99m Mertiatide