Characterization and Quality Control Analysis of 99mTc-Bicisate

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TABLE 1

Radiochemical Purity of ^99mTc-ECD Stored at Room Temperature

Analysis method	% RCP at time after reconstitution (mean ± SE)				Accuracy of method (%)
Analysis method		30 min	120 min	360 min	Accuracy of method (%)
Baker-Flex SG/EtAc	98.3 ± 0.8 (n = 5)	—	—	1.8
W17/EtAc	97.8 ± 0.3 (n = 19)	98.8 ± 0.8 (n = 3)	98.7 ± 0.3 (n = 3)	1.3
C18/saline, regular	98.2 ± 0.2 (n = 19)	98.0 ± 0.5 (n = 3)	99.0 ± 0.4 (n = 3)	1.0
C18/saline, fast	93.8 ± 0.4 (n = 19)	93.8 ± 0.5 (n = 3)	94.8 ± 0.4 (n = 3)	1.8
ITLC SG/saline	97.4 ± 0.1 (n = 3)	98.6 ± 0.0 (n = 3)	97.0 ± 0.3 (n = 3)	0.2
SAX/WFI	96.0 ± 1.2 (n = 3)	—	—	2.1

SG = silica gel; EtAc = ethylacetate; W17 = Whatman 17; SAX = strong anion exchange.

TABLE 2

Comparison of Analysis Methods

Analysis method	P value at time after reconstitution
		W17/EtAc					C18/saline, regular				ITLC SG/saline
		30 min	120 min	360 min	30 min	120 min	360 min	30 min	120 min	360 min
Baker-Flex SG/EtAc	0.56	—	—	0.71	—	—	0.24	—	—
W17/EtAc	—	—	—	0.80	0.24	0.37	0.73	0.45	0.03
C18/saline, regular	—	—	—	—	—	—	0.51	0.20	0.01
C18/saline, fast	—	—	—	<0.001	<0.001	<0.001	—	—	—

TABLE 3

Radiochemical Purity of ^99mTc-EDTA