Simplified Method for Determining the Radiochemical Purity of 99mTc-MAG3

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FIGURE 1.
Distribution of ^99mTc-MAG3 in 2.5-mL fractions of solution B. Error bars indicate SDs.
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FIGURE 2.
Relationship between ITLC method and simplified SPE method.

TABLE 1

Comparison of SPE Methods for Determination of RCP of ^99mTc-MAG3

Step	European method	American method
Preparation	10 mL of ethanol, 10 mL of HCl at 1 mmol/L, and 5 mL of air	10 mL of ethanol, 10 mL of HCl at 1 mmol/L, and 5 mL of air
Solution A (hydrophilic impurities)	5 mL of HCl at 1 mmol/L and 5 mL of 0.5% ethanol-phosphate buffer	10 mL of HCl at 1 mmol/L
Solution B (^99mTc-MAG3)	10 mL of 7% ethanol-phosphate buffer	10 mL of 1:1 ethanol:0.9% saline
Lipophilic impurities + colloid	10 mL of ethanol	Residue counted

TABLE 2

Description of Simplified Method

Step	Simplified method
Preparation	5 mL of ethanol and 5 mL of HCl at 1 mmol/L
Solution A (hydrophilic impurities)	5 mL of HCl at 1 mmol/L
Solution B (^99mTc-MAG3)	5 mL of 1:1 ethanol:water
Lipophilic impurities + colloid	Residue counted

TABLE 3

Comparison of Distribution of Radioactivity Determined by 3 SPE Methods

Fraction	European	American	Simplified
Hydrophilic impurities	4.33 ± 0.73	5.24 ± 0.89	3.54 ± 1.78
^99mTc-MAG3, fraction 1	74.36 ± 6.10	68.44 ± 5.00	87.47 ± 2.97
^99mTc-MAG3, fraction 2	17.45 ± 6.48	20.42 ± 4.28	7.70 ± 1.84
^99mTc-MAG3, fraction 3	1.81 ± 0.41	3.06 ± 1.71	NA
^99mTc-MAG3, fraction 4	1.03 ± 0.28	1.52 ± 0.59	NA
Lipophilic impurities + colloid	1.03 ± 0.28	1.32 ± 0.40	1.29 ± 0.36