Development of a low level detection method for 2-chloromalonaldehyde in active pharmaceutical ingredients by HILIC separation
| Autor: | Lorrie Berwick, Thomas P. Loughlin, Justin R. Denton |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Detection limit
Active ingredient Chromatography 010405 organic chemistry Chemistry General Chemical Engineering Hydrophilic interaction chromatography 010401 analytical chemistry General Engineering 01 natural sciences Method development 0104 chemical sciences Analytical Chemistry chemistry.chemical_compound Reagent Trace analysis Thiazole Chloromalonaldehyde |
| Zdroj: | Analytical Methods. 8:4659-4663 |
| ISSN: | 1759-9679 1759-9660 |
| DOI: | 10.1039/c6ay01257d |
| Popis: | 2-Chloromalonaldehyde (2-ClMA) is utilized in the pharmaceutical sector as a reagent to form thiazole heterocycles which can be further functionalized. This present work describes a hydrophilic interaction chromatography (HILIC) strategy for the trace analysis of 2-ClMA in pharmaceutical materials. Several method development aspects as well as a general mutagentic impurity control strategy for 2-ClMA are reviewed and discussed. The method as described has a reporting quantitation limit (QL) of 1 ppm and a reporting detection limit of 0.4 ppm for 2-ClMA with respect to a sample concentration of 10 mg mL−1. |
| Databáze: | OpenAIRE |
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