Control and analysis of hydrazine, hydrazides and hydrazones-Genotoxic impurities in active pharmaceutical ingredients (APIs) and drug products

被引：141

作者：

Elder, D. P. ^{[2
]}

Snodin, D. ^{[3
]}

Teasdale, A. ^{[1
]}

机构：

[1] AstraZeneca, AstraZeneca R&D, Loughborough LE11 5RH, Leics, England

[2] GlaxoSmithKline R&D, Ware SG12 0DP, Herts, England

[3] Xiphora Biopharma Consulting, Bristol BS6 7BG, Avon, England

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2011年 / 54卷 / 05期

关键词：

Hydrazine; Genotoxic; Derivatisation; Chromatography; Spectroscopy; CAPILLARY-ELECTROPHORESIS; CHROMATOGRAPHIC METHOD; DEGRADATION-PRODUCTS; DOSAGE FORMS; HPLC; DERIVATIVES; STABILITY; METHYLHYDRAZINE; FORMULATIONS; MUTAGENICITY;

D O I：

10.1016/j.jpba.2010.11.007

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

This is the latest of a series of reviews focused on the analysis of genotoxic impurities. This review summarises the analytical approaches reported in the literature relating to hydrazine, hydrazines, hydrazides and hydrazones. It is intended to provide guidance for analysts needing to develop procedures to control such impurities, particularly where this is due to concerns relating to their potential genotoxicity. Of particular note is the wide variety of techniques employed, both chromatographic and spectroscopic, with most involving derivatisation. Such a wide variety of options allow the analyst a real choice in terms of selecting the most appropriate technique specific to their requirements. Several generic methodologies, covering the three main analytical approaches; i.e. HPLC (high performance liquid chromatography), GC (gas chromatography) and IC (ion chromatography), are also described. (C) 2010 Elsevier B.V. All rights reserved.

引用

页码：900 / 910

页数：11

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