Page 21 - ARNM-2-3

Advances in Radiotherapy &

Nuclear Medicine

REVIEW ARTICLE
Pharmacopeial parametric release strategy

in microbiological quality control of
radiopharmaceuticals

Prasad Thota * , Bhavna Kumari 1 , Anil Kumar Teotia , Sachin Kumar 1 ,
1
1
Manoj Kumar Pandey 1 , Bikash Medhi 2 , Rakesh Kumar Sharma 3 ,
and Rajeev Singh Raghuvanshi 1
1 Microbiology Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare,
Government of India, Ghaziabad, Uttar Pradesh, India
2 Department of Pharmacology, Postgraduate Institute of Medical Education and Research,
Chandigarh, India
3 Department of Pharmaceutical Sciences, Shree Guru Gobind Singh Tricentenary University,
Gurugram, Haryana, India

Abstract

Nuclear medicine is used to assess body functionality at various levels of biological
organization and is increasingly employed for both diagnostic and therapeutic
purposes. Nearly 5% of radiopharmaceuticals are used therapeutically, whereas
approximately 95% are used for diagnosis. Diagnostic radiopharmaceuticals are
generally considered safe because they are administered in subpharmacological
doses, and the radiotracer components are employed in minimal doses. Consequently,
*Corresponding author: the radiation exposure to the body during nuclear medicine investigations is
Prasad Thota
(prasad.ipc@gov.in) typically low. However, when radiopharmaceuticals are used for therapeutic
applications such as tumor ablation and bone pain palliation, the emitted radiation
Citation: Thota P, Kumari B,
Teotia AK, et al. Pharmacopeial is highly localized and potent. Radiotracers and radiation doses are more carefully
parametric release strategy in selected for young patients, as the radiation-induced risk of adverse health effects is
microbiological quality control greater in children than in adults. Radiopharmaceutical preparations should adhere
of radiopharmaceuticals. to the established standards of pharmacopoeia worldwide to ensure safety and
Adv Radiother Nucl
Med. 2024;2(3):3619. efficacy. Adherence to current good manufacturing practices, sterility, and good
doi: 10.36922/arnm.3619 radiation practices are prerequisites for ensuring effective quality assurance and
Received: May 9, 2024 quality control systems during radiopharmaceutical preparation. The quality control
test parameter for radiopharmaceuticals primarily involves physicochemical and
Accepted: July 17, 2024
biological tests. However, significant concerns exist regarding the biological testing
Published Online: September 11, of radiopharmaceuticals, necessitating their parametric release. The time-intensive
2024 traditional sterility test, bacterial endotoxin test, and rabbit pyrogen tests have been
Copyright: © 2024 Author(s). critical quality control issues due to the short half-lives of most radiopharmaceuticals,
This is an Open-Access article as they should be dispensed at the earliest to ensure optimal diagnostic/therapeutic
distributed under the terms of the
Creative Commons Attribution benefit. Therefore, manufacturers of radiopharmaceuticals, dispensers, and nuclear
License, permitting distribution, medicine specialists should be cognizant of the issues posed by biological quality
and reproduction in any medium, control as a primary obstacle to ensuring consistent quality through parametric
provided the original work is
properly cited. release from a compendial test method standpoint.
Publisher’s Note: AccScience
Publishing remains neutral with Keywords: Radiopharmaceuticals; Quality control; Pharmacopoeia; Bacterial endotoxin;
regard to jurisdictional claims in
published maps and institutional Pyrogen; Sterility; Parametric release
affiliations

Volume 2 Issue 3 (2024) 1 doi: 10.36922/arnm.3619