T/CI 046-2021 Active Group standards

T/CI 046-2021 The quality standards for medical germanium [68Ge] gallium [68Ga] generators and radioactive drugs for medical use

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 046-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical radiation equipment

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 germanium [68Ge]/gallium [68Ga] generators and medical gallium [68Ga] radiopharmaceuticals in medical institutions. Given the special nature of medical gallium [68Ga] radiopharmaceuticals, and to ensure the quality and safe and effective use of medical gallium [68Ga] radiopharmaceuticals, this guideline is formulated in accordance with the Pharmaceutical Management Law and the Regulations on the Management of Radioactive Drugs. This guideline applies to medical institutions (with a Class IV Radioactive Drug Use License) that prepare medical gallium [68Ga] radiopharmaceuticals themselves for quality control of medical gallium [68Ga] radiopharmaceuticals. Gallium [68Ga] radiopharmaceuticals used for other purposes may refer to this guideline for implementation. Main technical content: 4. Technical specifications and quality control requirements for medical germanium [68Ge]/gallium [68Ga] generators. The germanium [68Ge]/gallium [68Ga] generator consists of the parent nucleus germanium [68Ge] (with a half-life of approximately 271 days) and the daughter nucleus gallium [68Ga]. The parent nucleus germanium [68Ge] in the germanium [68Ge]/gallium [68Ga] generator has a long lifespan. Through the adsorption of germanium [68Ge] by a specific filling material, an ionic gallium [68Ga] can be obtained using a rinsing solution. The selection of filling materials and rinsing agents should focus on the specificity and stability of chemical separation. Currently, commercially available medical germanium [68Ge]/gallium [68Ga] generators use generator filling dyes and rinsing agents including TiO2 (0.1 mol/L HCl, Eckert & Ziegler GalliaPharm), SiO2 (0.05 mol/L HCl, ITG Isotope Technologies Garching GmbH), and SnO2 (0.6 mol/L HCl, iThemba LABORATORIES). For medical institutions that prepare medical gallium [68Ga] radiopharmaceuticals themselves, before using a new medical germanium [68Ge]/gallium [68Ga] gen