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
收藏
页码：119 / 130
页数：12
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