Study on drug substance degradation under headspace GC conditions of residual solvent analysis

Author:

Zhao Hua1ORCID,Phillipson Doug2,Li Jiangwei1ORCID,Wu Frank1ORCID

Affiliation:

1. Neurocrine Biosciences Inc, 12780 El Camino Real, San Diego, CA 92130, USA

2. 14148 Bahama Cove, Del Mar, CA 92014, USA

Abstract

The mechanism and kinetics of the isobutyraldehyde formation had been studied when the drug substance that contains an amino acid group is under the headspace oven temperature during residual solvent testing.

Publisher

Royal Society of Chemistry (RSC)

Subject

General Engineering,General Chemical Engineering,Analytical Chemistry

Reference4 articles.

1. H.Lee , Control of chloroethane in raw materials and drug substances using headspace/gas chromatography analysis , Pharmaceutical Industry Practices on Genotoxic Impurities . 2014 , p. 14

2. Kinetics and Mechanism of Gas-Phase Thermolysis Using Headspace-Gas Chromatographic Analysis

3. The Strecker Degradation of Amino Acids: Newer Avenues for Flavor Formation

4. The reaction kinetics for the formation of Strecker aldehydes in low moisture model systems and in plant powders

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