Characterization and quality control analysis of 99mTc-bicisate

Area of Science:

• Radiopharmaceutical Chemistry
• Analytical Chemistry
• Quality Control

Background:

• Accurate determination of radiochemical purity (RCP) is crucial for radiopharmaceuticals like (99m)Tc-bicisate.
• Traditional paper chromatography and newer mini cartridge methods are used for RCP assessment.
• Evaluating and comparing these methods is essential for optimizing quality control protocols.

Purpose of the Study:

• To compare the efficacy of mini cartridge methods versus paper chromatography for determining the RCP of (99m)Tc-bicisate.
• To identify the most efficient and reliable method for routine quality control.

Main Methods:

• Four methods were evaluated: Whatman 17 paper/ethyl acetate, instant thin-layer chromatography (ITLC) silica gel/saline, C18 mini cartridge/saline, and strong anion exchange mini cartridge/water.
• These were compared against the manufacturer's method for RCP determination of (99m)Tc-bicisate.
• Radiochemical purity was assessed at 30 minutes post-reconstitution.

Main Results:

• Paper and cartridge methods generally yielded high RCPs (97%-98%).
• The C18 mini cartridge/saline method provided results in 2 minutes, demonstrating simplicity and speed.
• The ITLC silica gel/saline method had a time disadvantage, and the strong anion exchange/WFI method showed slight underestimation.

Conclusions:

• The C18 mini cartridge/saline method is recommended as the simplest, fastest, and most suitable for routine RCP determination of (99m)Tc-bicisate.
• Method choice impacts RCP accuracy, particularly with variations in flow rate for the C18/saline method.
• Further investigation into the strong anion exchange/WFI method is warranted due to potential formulation influences.