TABLE 7

Provisional Release Specifications for Sodium Pertechnetate ^99mTc Injection Manufactured with Cyclotron

Parameter/trace	Test method	Provisional specifications	Validation batches (n = 5)	European Pharmacopeia	U.S. Pharmacopeia
Appearance	Visual	Clear, colorless	Conform	Clear, colorless	—
pH	pH test strip	4.0−8.0	5.0−5.5	4.0−8.0	4.5−7.5
Radiochemical identity	Thin-layer chromatography	R_f > 0.7^*	0.8−0.9	R_f ∼0.6	R_f ∼0.9% ± 10%
Radiochemical purity	Thin-layer chromatography	≥95%	>98%	≥95%	≥95%
Radionuclidic identity	γ-ray spectrometry	γ ray at 141 keV	141 keV	140 keV	140 keV
Radioisotopic purity	γ-ray spectrometry	>99.4%	>99.98%	>99.88%	>99.935%
Other nuclides (not technetium)	γ-ray spectrometry	Undetectable γ ray at 569, 658, 740 keV^†	Conform	≤0.12%^‡	≤0.065%^‡

↵* Validated for silica-gel/acetone system; R_f for sodium pertechnetate in other systems may be different.
↵† γ-ray peaks correspond to ⁹⁶Nb (569 keV), ⁹⁷Nb (658 keV), and ⁹⁹Mo (740 keV).
↵‡ Trace amounts of ⁹⁹Mo, as well as other nontechnetium radionuclides, are permitted in ^99mTc eluate.