VALIDATION OF A HEADSPACE GAS CHROMATOGRAPHY METHOD FOR VOLATILE RESIDUAL SOLVENTS IDENTIFICATION IN RADIOPHARMACEUTICALS

被引：0

作者：

Tudoroiu-cornoiu, Maria-Roxana ^{[1
,2
]}

Chilug, Elena Livia ^{[2
]}

Ion, Ion ^{[1
]}

Niculae, Dana ^{[2
]}

机构：

[1] Natl Univ Sci & Technol Politehn Bucharest, Fac Chem Engn & Biotechnol, Doctoral Sch Appl Chem & Mat Sci, Bucharest, Romania

[2] Horia Hulubei Natl Inst R&D Phys & Nucl Engn, Magurele, Romania

来源：

UNIVERSITY POLITEHNICA OF BUCHAREST SCIENTIFIC BULLETIN SERIES B-CHEMISTRY AND MATERIALS SCIENCE | 2024年 / 86卷 / 04期

关键词：

residual solvent; chemical purity; HS-GC; validation; Cu-64]Cu- DOTA-NT;

D O I：

暂无

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

The following study presents the development and validation of a headspace gas chromatography (HS-GC) analytical method for determining five residual solvents, frequently encountered in radioactive drugs. Measurement of residual solvents is a critical step in the testing and release of pharmaceutical products. The method demonstrated high accuracy and precision, being specific and fast, under the regulations of the European Pharmacopoeia.

引用

页码：119 / 130

页数：12