T/CI 047-2021 Active Group standards

T/CI 047-2021 Quality standard for medical lutetium [177Lu] and its radioactive drug

Publish Date: 2022-01-01 Implement Date: 2022-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CI 047-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Other standards related to nuclear energy

Publish Date: 2022-01-01

Implement Date: 2022-01-01

Scope

Scope: This standard specifies the quality control standards for the use of lutetium [177Lu] and its radioactive drugs in medical institutions. Given the special nature of medical lutetium [177Lu] radioactive drugs, in order to ensure the quality and safe and effective use of medical lutetium [177Lu] radioactive drugs, in accordance with the "Drug Administration Law" and the "Regulations on the Administration of Radioactive Drugs", these guidelines have been formulated. These guidelines apply to the quality control of medical lutetium [177Lu] radioactive drugs in medical institutions that prepare lutetium [177Lu] radioactive drugs themselves. Lutetium [177Lu] radioactive drugs used for other purposes can be implemented with reference to these guidelines. Main technical content: 4. Physical properties and quality control of medical lutetium [177Lu]. Lutetium [177Lu] is a radioactive nuclide of the element lutetium, with a half-life of about 6.67 days. Lutetium [177Lu] emits three types of β-particles with energies of 498 keV (79.3%), 380 keV (9.1%) and 176 keV (12.2%). These particles have relatively low energy and a short average range in tissue (≤ 2.2 mm). When irradiating lesions, it causes less bone marrow suppression, making it a very suitable radioactive nuclide for treatment. At the same time, lutetium [177Lu] also emits γ-rays with energies of 208 keV (11.00%), 113 keV (6.40%), 321 keV (0.22%), 250 keV (0.21%) and 76 keV (0.15%), which can be used for nuclear medicine imaging. Based on these characteristics, lutetium [177Lu] has been used in the research of various radioactive drugs. 5. Quality control of medical lutetium [177Lu] radioactive drugs 5.1 Chemical labeling of medical lutetium [177Lu] radioactive drugs The process of labeling medical lutetium [177Lu] mainly includes the labeling reaction (which depends on pH, reaction time, temperature and buffer system, etc.) and the purification of the labeled products. Metal ions interfere significantly with