T/CIRA 3-2019 [Carbon-13]-urea

Scope

Scope: This standard specifies the requirements, test methods, inspection rules, packaging, labeling, transportation, and storage for pharmaceutical-grade carbon [13C]-urea. This standard applies to the production and delivery of pharmaceutical-grade carbon [13C]-urea prepared by chemical synthesis using 13CO as the raw material, for use in 13C breath test diagnosis of Helicobacter pylori. The carbon [13C]-urea covered by this standard is intended for use in 13C breath diagnostic reagents. Therefore, in addition to meeting the requirements for isotope abundance and content indicators of conventional stable isotope-labeled chemical products, it must also meet the limits for various impurities in oral diagnostic reagents. Therefore, during the preparation of this standard, it is necessary to comply with the principles of product standard preparation while meeting the requirements for indicators, limits, and circulation of this "pharmaceutical" product. At the same time, it is necessary to maintain coordination and consistency with current standards for isotope products and the nuclear industry. Main technical content: During the preparation of this standard, extensive reference was made to current norms and standards such as the *Chinese Pharmacopoeia*, the *United States Pharmacopoeia*, the *European Pharmacopoeia*, and industry standard HG/T 4138-2010 *Stable Isotope 13C-Urea*. Based on the technical content required by product standards, this standard comprises ten sections, namely: 1 Scope, 2 Normative References, 3 Molecular Structure Formula, 4 Terms and Definitions, 5 Symbols and Abbreviations, 6 Requirements, 7 Test Methods, 8 Inspection Rules, 9 Labeling, 10 Packaging, Transportation, and Storage. 1. Determination of the Standard Name and Scope Since the carbon [13C]-urea covered by this standard is a diagnostic reagent and an oral medication, the naming of "Pharmaceutical-Grade Urea [13C]" needs to comply with standard naming rules while meeting th

Development Information

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