Simultaneous quantitation of trace level hydrazine and acetohydrazide in pharmaceuticals by benzaldehyde derivatization with sample ‘matrix matching’ followed by liquid chromatography–mass spectrometry

Author:

Cui Li,Jiang Kaina,Liu David Q.,Facchine Kevin L.

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference32 articles.

1. Control and analysis of hydrazine, hydrazides and hydrazones-genotoxic impurities in active pharmaceutical ingredients (APIs) and drug products;Elder;J. Pharm. Biomed. Anal.,2011

2. Human health perspective on environmental exposure to hydrazines: a review;Choudhary;Chemosphere,1998

3. Direct liquid chromatographic determination of hydrazines: a review;Smolenkov;Talanta,2012

4. M7: assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk;ICH;Fed. Regist.,2015

5. A generic approach for the determination of trace hydrazine in drug substances using in situ derivatization-headspace GC–MS;Sun;J. Pharm. Biomed. Anal.,2009

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