T/CIRA 9-2020 Active Group standards

T/CIRA 9-2020 Lutetium trichloride [177Lu] solution

Publish Date: 2020-12-28 Implement Date: 2021-03-01 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/CIRA 9-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Isotope-labeled compounds

ICS Name: Other standards related to nuclear energy

Publish Date: 2020-12-28

Implement Date: 2021-03-01

Scope

Scope: This document specifies the technical requirements, testing methods, inspection rules, labeling, quality inspection reports, user manuals, packaging, transportation, and storage of lanthanum trichloride [177Lu] solution. This document applies to the production and use of lanthanum trichloride [177Lu] solution for preparing lanthanum [177Lu]-labeled drugs; lanthanum trichloride [177Lu] solution for other purposes can be implemented with reference to this document. Main technical content: The main technical content is contained in the "Technical Requirements, Testing Methods, and Inspection Rules". For some items under "Technical Requirements", the content is partially referenced from the European Pharmacopoeia 9.3, 07/2017:2798, but considering that many items in the EP standard are not suitable for the actual domestic situation and the quality requirements of lanthanum trichloride [177Lu] that need to be limited in this standard, the EP standard is only used as a reference. The determination of the main technical content is mainly based on the actual domestic situation described in the "Compilation Principles" and the validation of the quality inspection methodology. The corresponding "Testing Methods" are mainly referenced from the relevant chapters of the Pharmacopoeia of the People's Republic of China 2020 Edition. And the validation has been carried out.