A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients
Joint Authors
Daoud Agha Dit Daoudy, Bashir
Al-Khayat, Mohammad Ammar
Karabet, Francois
Al-Mardini, Mohammad Amer
Source
Journal of Analytical Methods in Chemistry
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-03-04
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Formaldehyde is a highly reactive impurity that can be found in many pharmaceutical excipients.
Trace levels of this impurity may affect drug product stability, safety, efficacy, and performance.
A static headspace gas chromatographic method was developed and validated to determine formaldehyde in pharmaceutical excipients after an effective derivatization procedure using acidified ethanol.
Diethoxymethane, the derivative of formaldehyde, was then directly analyzed by GC-FID.
Despite the simplicity of the developed method, however, it is characterized by its specificity, accuracy, and precision.
The limits of detection and quantification of formaldehyde in the samples were of 2.44 and 8.12 µg/g, respectively.
This method is characterized by using simple and economic GC-FID technique instead of MS detection, and it is successfully used to analyze formaldehyde in commonly used pharmaceutical excipients.
American Psychological Association (APA)
Daoud Agha Dit Daoudy, Bashir& Al-Khayat, Mohammad Ammar& Karabet, Francois& Al-Mardini, Mohammad Amer. 2018. A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients. Journal of Analytical Methods in Chemistry،Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1176369
Modern Language Association (MLA)
Daoud Agha Dit Daoudy, Bashir…[et al.]. A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients. Journal of Analytical Methods in Chemistry No. 2018 (2018), pp.1-8.
https://search.emarefa.net/detail/BIM-1176369
American Medical Association (AMA)
Daoud Agha Dit Daoudy, Bashir& Al-Khayat, Mohammad Ammar& Karabet, Francois& Al-Mardini, Mohammad Amer. A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients. Journal of Analytical Methods in Chemistry. 2018. Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1176369
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1176369