Issue 7, 2023
From the journal:

Analytical Methods

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

Hua Zhao, ORCID logo *a   Doug Phillipson,b   Jiangwei Li ORCID logo a  and  Frank Wu ORCID logo a  

* Corresponding authors

a Neurocrine Biosciences Inc, 12780 El Camino Real, San Diego, CA 92130, USA
E-mail: lzhao@neurocrine.com

b 14148 Bahama Cove, Del Mar, CA 92014, USA

Abstract

Isobutyraldehyde (IBA) was detected in drug substance (DS) containing an amino acid group using a headspace-gas chromatography (HS-GC) method. High-performance liquid chromatography-mass-spectrometry (HPLC-MS) data from an HS vial confirmed that IBA was a degradant. The HS-GC method was modified to minimize IBA by keeping the HS oven temperature lower than 80 °C.

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

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Article information

DOI
https://doi.org/10.1039/D2AY02013K
Article type
Communication
Submitted
14 Dec 2022
Accepted
19 Jan 2023
First published
25 Jan 2023
This article is Open Access
Creative Commons BY license

Anal. Methods, 2023,15, 901-905

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

H. Zhao, D. Phillipson, J. Li and F. Wu, Anal. Methods, 2023, 15, 901 DOI: 10.1039/D2AY02013K

This article is licensed under a Creative Commons Attribution 3.0 Unported Licence. You can use material from this article in other publications without requesting further permissions from the RSC, provided that the correct acknowledgement is given.

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