GC-MS和LC-MS技术在原料药中胺类物质直接分析中的应用

IF 0.4 4区 医学 Q4 PHARMACOLOGY & PHARMACY
A. Witkowska, E. Stolarczyk, A. Groman, M. Zezula
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引用次数: 0

摘要

有机挥发性化学物质,如胺,通常不能被实际的制造技术完全去除,因此它们在大多数药品中的含量很低。根据良好的生产规范和为了患者的安全,必须严格控制药品中对人体健康有害的胺的含量。此外,由于仲胺、叔胺和其他胺衍生物等残留杂质(在一定条件下)被报道为致癌性n -亚硝胺(NAs)的前体,因此对药品中挥发性胺的分析近年来成为分析化学家感兴趣的新兴课题。本文采用气相色谱-质谱联用技术和液相色谱-质谱联用技术,建立了药物活性成分(原料药)中叔丁胺(TBA)、吡啶、4-氟苯胺(4-FA)、二异丙基乙胺(DIPEA)和四丁基硫酸氢铵(TBAHS)的控制方法。验证结果清楚地表明分析方法适合其预期目的。所有显示的验证结果均符合ICH Q2R1验证指南和Q3A R2残留杂质指南的要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of GC-MS and LC-MS techniques for direct analysis of amines in pharmaceutical substances
Organic volatile chemicals such as amines are often not completely removed by practical manufacturing techniques and consequently their low levels are present in most pharmaceuticals. Based on good manufacturing practices and for the safety of the patients the level of hazardous for human health amines in pharmaceuticals have to be strictly controlled. Moreover, analysis of volatile amines in drug product has become recently an emerging topic of interest for analytical chemists since such residual impurities as: secondary amines, tertiary amine and other amine derivatives (in certain condition) have been reported to be a precursors of carcinogenic N-nitrosamines (NAs). In this study we present five new methods for control of such amines as: tert-butylamine (TBA), pyrrolidine, 4-fluoroaniline (4-FA), diisopropyl-ethylamine (DIPEA) and tetrabutylammonium hydrogensulfate (TBAHS) in pharmaceutical active ingredients (APIs) using GC-MS and LC-MS techniques. The validations results clearly demonstrate that the analytical procedures are suitable for their intended purpose. All revealed validations results meet the requirements of the ICH Q2R1 validation guidelines and the Q3A R2 guideline for residual impurities.
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来源期刊
CiteScore
0.80
自引率
0.00%
发文量
74
审稿时长
6-12 weeks
期刊介绍: The international journal of the Polish Pharmaceutical Society is published in 6 issues a year. The journal offers Open Access publication of original research papers, short communications and reviews written in English, in all areas of pharmaceutical sciences. The following areas of pharmaceutical sciences are covered: Analysis, Biopharmacy, Drug Biochemistry, Drug Synthesis, Natural Drugs, Pharmaceutical Technology, Pharmacology and General. A bimonthly appearing in English since 1994, which continues “Acta Poloniae Pharmaceutica”, whose first issue appeared in December 1937. The war halted the activity of the journal’s creators. Issuance of “Acta Poloniae Pharmaceutica” was resumed in 1947. From 1947 the journal appeared irregularly, initially as a quarterly, then a bimonthly. In the years 1963 – 1973 alongside the Polish version appeared the English edition of the journal. Starting from 1974 only works in English are published in the journal. Since 1995 the journal has been appearing very regularly in two-month intervals (six books a year). The journal publishes original works from all fields of pharmacy, summaries of postdoctoral dissertations and laboratory notes.
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