A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients
| Autor: | Mohammad Amer Al-Mardini, Francois Karabet, Mohammad Ammar al-Khayat, Bashir Daoud Agha Dit Daoudy |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Detection limit
lcsh:QD71-142 Chromatography Article Subject General Chemical Engineering 010401 analytical chemistry lcsh:Analytical chemistry Formaldehyde 02 engineering and technology Derivative 021001 nanoscience & nanotechnology 01 natural sciences 0104 chemical sciences Computer Science Applications Analytical Chemistry chemistry.chemical_compound chemistry Impurity Drug product 0210 nano-technology Derivatization Instrumentation Research Article |
| Zdroj: | Journal of Analytical Methods in Chemistry Journal of Analytical Methods in Chemistry, Vol 2018 (2018) |
| ISSN: | 2090-8873 2090-8865 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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