Determination of residual phenylhydrazines in drug substances by high-performance liquid chromatography with pre-column derivatization-Reference-Cited by-同舟云学术

Determination of residual phenylhydrazines in drug substances by high-performance liquid chromatography with pre-column derivatization

Published:2019 Issue:48 Volume:11 Page:6146-6152
ISSN:1759-9660
Container-title:Analytical Methods
language:en
Short-container-title:Anal. Methods

Author:

Li Jiaxin¹²³⁴,Nadine Joelle Eyoro Noah¹²³⁴,Yang Qian⁵⁶⁴,Zheng Feng¹²³⁴^ORCID,Liu Wenyuan¹²³⁴^ORCID,Liu Jing¹²³⁴^ORCID

Affiliation:

1. Department of Pharmaceutical Analysis

2. China Pharmaceutical University

3. Nanjing 210009

4. China

5. Tianjin Institute for Drug Control

6. Tianjin 300070

Abstract

A selective, sensitive and general HPLC method with pre-column derivatization was developed for the determination of residual phenylhydrazines (known as genotoxic impurities) in drug substances.

Funder

Priority Academic Program Development of Jiangsu Higher Education Institutions

Fundamental Research Funds for the Central Universities

Publisher

Royal Society of Chemistry (RSC)

Subject

General Engineering,General Chemical Engineering,Analytical Chemistry

Link

http://pubs.rsc.org/en/content/articlepdf/2019/AY/C9AY02231G

Reference28 articles.

1. Regulation of genotoxic and carcinogenic impurities in drug substances and products

2. Strategies for the identification, control and determination of genotoxic impurities in drug substances: A pharmaceutical industry perspective

3. Recent advances in trace analysis of pharmaceutical genotoxic impurities

4. Genotoxic Impurities in Pharmaceutical Manufacturing: Sources, Regulations, and Mitigation

5. Guideline on The Limits of Genotoxic Impurities , European Medicines Agency (EMA) , 2006 , https://www.ema.europa.eu/en

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