Page 23 - ARNM-2-3

Advances in Radiotherapy
& Nuclear Medicine QC parameters in radiopharmaceuticals

for diagnostic categories, six are for therapeutic categories, of radiopharmaceuticals were a helpful resource for setting
and one is applied for both diagnosis and therapy. For quality requirements for radiopharmaceuticals prepared
8,9
the rest of the pharmacopeias, BP 2023 and European on a modest scale and the non-radioactive labeling
Pharmacopoeia (EP) 11.0 consists of 83 monographs, USP precursors used in their preparation. 22
2022 comprises 43 monographs, 11 edition of International
th
Pharmacopoeia comprises 25 monographs, Chinese 5. Key elements of radiopharmaceuticals
Pharmacopoeia (CP) 2015 consists of 30 monographs, quality control
and 18 edition of Japanese Pharmacopoeia (JP) consists Quality controls are crucial in any production or formulation
th
of 13 monographs concerning the radiopharmaceutical line in the pharmaceutical sector. The same applies to
preparations as mentioned in Table 1 in detail. 10-15 Tabulation
of pharmacopeial requirements for a comprehensive list of radiopharmaceutical formulations. Radiopharmaceuticals
radiopharmaceuticals is addressed in Table 2. are subject to the same quality control processes as non-
radioactive medications. Quality control procedures
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4. Significance of quality control in should always be performed for radiopharmaceutical
radiopharmaceuticals preparation and before patient administration, except
for the parametric release batch, to ensure optimal
When it comes to testing, quality control, a part of quality radiopharmaceutical products. Due to the interaction
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assurance, plays a major role. The use of procedures, between pharmaceutical and radioactive characteristics,
tests, analytical methods, and acceptance criteria to quality monitoring of radiopharmaceuticals is essential
evaluate the quality of radiopharmaceuticals, materials, for independent yet connected reasons. Pharmaceutical
and components is known as quality control. The vast guidelines were created to ensure that patients cannot
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majority of radiopharmaceuticals used in nuclear medicine be harmed by pyrogenic, microbiological, or particle
have wide applications in diagnostic, therapeutic, and contamination. The radioactivity, radiochemical purity,
theranostic and are injected intravenously into patients and radionuclidic purity are all ensured by a radioactive
as part of both diagnosis and therapy, which normally parameter, which helps to keep the desired radiation dose
take a few minutes for administration to each patient. 5,16,17 of patients to a minimum. 17
They typically contain trace amounts of the active
components and a radioisotope to facilitate scintigraphic The quality control tests for radiopharmaceuticals and
imaging or biodistribution study and are delivered once cold kits fall into physicochemical and biological tests.
or more. Radiopharmaceutical composition changes The physicochemical analyses ascertain the sample pH,
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over time, which is associated with radioactive decay. ionic strength, osmolality, and physical state, especially if
This necessitates using semi-manufactured goods such it is a colloid, as well as the quantity of radionuclidic and
as radionuclide generators, precursors, and kits since radiochemical pollutants, while the material’s sterility,
the physical half-life of the radionuclide is frequently so apyrogenicity, and toxicity are demonstrated by the
short that the final preparation must be completed right biological tests. The manufacturers carry out some of
away before administration to the patient. Hence, it is these QC procedures, whereas others need to be done
important to consider the standards of generators, kits, by the dispensing staff. The primary components of
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and other semi-manufactured goods when evaluating radiopharmaceutical quality control parameters are
the safety and effectiveness of radiopharmaceuticals. depicted in Figure 1.
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Since radiopharmaceuticals are meant to be administered Here, we review the most significant and
to patients, they must undergo rigorous quality control widespread biological quality control procedures for
procedures to ensure the formulations adhere to the
established radiological and pharmaceutical safety and radiopharmaceuticals, given their short half-lives.
efficacy standards. The radiopharmaceuticals used in 6. Biological quality control
1,20
the diagnostic nuclear medicine study must meet all these
standards. Adherence to the quality control standards One of the two types of radiopharmaceuticals is those
regarding therapeutic radiopharmaceuticals is also made with a half-life that is long enough to permit regular
essential because the patient’s life could be endangered sterility testing. Radiopharmaceuticals require retroactive
due to higher localized radiation, other side effects, and testing, which is the main distinction between their
toxicity. The Good Radiopharmacy Practice Guidelines sterility testing and that of conventional medications.
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published by the Radiopharmacy Committee of the However, because most radiopharmaceuticals are prepared
European Association of Nuclear Medicine on current and utilized in less than a week, there is insufficient time
Good Radiopharmaceuticals Practice in the preparation to perform the required sterility tests. The tests used
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Volume 2 Issue 3 (2024) 3 doi: 10.36922/arnm.3619