Validation of analytical methods for the quality control of 99mTc-PSMA-I&S radiopharmaceutical

Name: Boon-Uma Jowanaridhi

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Email : boonuma@tint.or.th

Name: Chotiwid Wiriyachailerd

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Name: Siriwat Thida

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Name: Krittika Somruedee

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

LCSH: Radiopharmaceuticals -- Quality control

LCSH: Nuclear medicine

LCSH: Prostate cancer

LCSH: Technetium

Abstract: Radiopharmaceuticals are radioactive drugs used in nuclear medicine for disease diagnosis and treatment. Similar to conventional pharmaceuticals, their quality must be rigorously controlled before patient administration to ensure safety, efficacy, and compliance with good manufacturing practices (GMP). Analytical methods employed for radiopharmaceutical testing must therefore be validated to confirm their reliability and reproducibility. This study aimed to verify and validate analytical methods used for the quality control of technetium-99m-labeled Prostate Specific Membrane Antigen–Imaging & Surgery (⁹⁹ᵐTc-PSMA-I&S), developed for prostate cancer diagnosis. Two key parameters were evaluated prior to administration: radionuclide identification and radiochemical purity. Gamma spectroscopy was employed for radionuclide identification and validated for specificity. Radio-thin layer chromatography (radio-TLC) was used to determine radiochemical purity, and this quantitative method was validated for accuracy, precision, specificity, limit of quantification, linearity, range, and robustness. The validation results demonstrated recovery values between 98–102%, with acceptable linearity in the concentration range of 0.1–2.5 mCi/mL. The relative standard deviation (RSD) of radiochemical purity measurements was below 1.9%. In conclusion, all validation parameters met the established criteria, confirming that the analytical methods are reliable and suitable for the quality control of ⁹⁹ᵐTc-PSMA-I&S radiopharmaceuticals.

King Mongkut's University of Technology North Bangkok. Central Library

Address: BANGKOK

Email: library@kmutnb.ac.th

Created: 2025

Modified: 2025-10-21

Issued: 2025-10-21

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BibliograpyCitation : In The Chemical Society of Thailand under the Patronage of Professor Dr. Her Royal Highness Princess Chulabhorn Krom Phra Srisavangavadhana and Suranaree University of Technology. Institute of Science. School of Chemistry. Pure and Applied Chemistry International Conference 2025 (PACCON 2025) (pp.31-35). Bangkok : The Chemical Society of Thailand under the Patronage of Professor Dr. Her Royal Highness Princess Chulabhorn Krom Phra Srisavangavadhana in association with the School of Chemistry, Institute of Science, Suranaree University of Technology, 2025

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