T/CIRA 8-2020 Active Group standards

T/CIRA 8-2020 Medicinal [14C] Urea

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 8-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Fertilizers and pesticides

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 specifications, test methods, inspection rules, labeling, packaging, transportation, and storage of pharmaceutical urea [14C]. This document is applicable to the quality control of pharmaceutical urea [14C] prepared by chemical synthesis using barium carbonate [14C] as a raw material. Main technical content: Based on the technical requirements of the product standard, this standard includes a total of 10 sections, namely: 1 Scope, 2 Normative Reference Documents, 3 Terms and Definitions, 4 Molecular Structure Formula, 5 Requirements, 6 Test Methods, 7 Inspection Rules, 8 Labeling, 9 Packaging, Transportation, and Storage, 10 Shelf Life. 1. The standard defines the requirements for urea [14C], including its appearance, identification, radioactive concentration or specific activity, radioactive nuclear purity, radiochemical purity, and chemical purity. It also provides the basis for the limit values of each indicator. 2. The standard defines the detection methods for the identification of urea [14C], its radioactive concentration or specific activity, radioactive nuclear purity, radiochemical purity, and chemical purity, and gives the details of each detection method.