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Shukla J, Vatsa R, Garg N, et al. Quality control of positron emission tomography radiopharmaceuticals: An institutional experience. Indian J Nucl Med. 2013;28(4):200-6doi: 10.4103/0972-3919.121963.
Shukla, J., Vatsa, R., Garg, N., Bhusari, P., Watts, A., & Mittal, B. R. (2013). Quality control of positron emission tomography radiopharmaceuticals: An institutional experience. Indian journal of nuclear medicine : IJNM : the official journal of the Society of Nuclear Medicine, India, 28(4), 200-6. https://doi.org/10.4103/0972-3919.121963
Shukla, Jaya, et al. "Quality control of positron emission tomography radiopharmaceuticals: An institutional experience." Indian journal of nuclear medicine : IJNM : the official journal of the Society of Nuclear Medicine, India vol. 28,4 (2013): 200-6. doi: https://doi.org/10.4103/0972-3919.121963
Shukla J, Vatsa R, Garg N, Bhusari P, Watts A, Mittal BR. Quality control of positron emission tomography radiopharmaceuticals: An institutional experience. Indian J Nucl Med. 2013 Oct;28(4):200-6. doi: 10.4103/0972-3919.121963. PMID: 24379528; PMCID: PMC3866663.
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Indian J Nucl Med. 2013 Oct;28(4):200-6. doi: 10.4103/0972-3919.121963.

Quality control of positron emission tomography radiopharmaceuticals: An institutional experience.

Indian journal of nuclear medicine : IJNM : the official journal of the Society of Nuclear Medicine, India

Jaya Shukla, Rakhee Vatsa, Nitasha Garg, Priya Bhusari, Ankit Watts, Bhagwant R Mittal

Affiliations

  1. Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, Punjab, India.

PMID: 24379528 PMCID: PMC3866663 DOI: 10.4103/0972-3919.121963

Abstract

PURPOSE OF THE STUDY: To study quality control parameters of routinely prepared positron emission tomography (PET) radiopharmaceuticals.

MATERIALS AND METHODS: Three PET radiopharmaceuticals fluorine-18 fluorodeoxyglucose (F-18 FDG), N-13 ammonia (N-13 NH3), and Ga-68 DOTATATE (n = 25 each), prepared by standardized protocols were used. The radionuclide purity, radiochemical purity, residual solvents, pH, endotoxins, and sterility of these radiopharmaceuticals were determined.

RESULTS: The physical half-life of radionuclide in radiopharmaceuticals, determined by both graphical and formula method, demonstrated purity of radionuclides used. pH of all PET radiopharmaceuticals used was in the range of 5-6.5. No microbial growth was observed in radiopharmaceutical preparations. The residual solvents, chemical impurity, and pyrogens were within the permissible limits.

CONCLUSIONS: All three PET radiopharmaceuticals were safe for intravenous administration.

Keywords: Gas chromatography; half-life; multichannel analyzer; pyrogen; sterility

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