Journal of Chromatography & Separation Techniques
Open Access
ISSN: 2157-7064
+44 1300 500008
ISSN: 2157-7064
+44 1300 500008
Justin R Denton
Manufacturing Division: Supply Analytical Services,
Rahway, NJ
Tanzania
Research Article
Development of a Method for Regioisomer Impurity Detection and
Quantitation within the Raw Material 3-Chloro-5-Fluorophenol by Gas
Chromatography
Author(s): Justin R Denton, Yun Chen and Thomas LoughlinJustin R Denton, Yun Chen and Thomas Loughlin
Control of regioisomer impurities within pharmaceutical raw materials, intermediates, and active pharmaceutical ingredients are of major concern for the pharmaceutical industry. If regioisomer impurities are possible, their detection and quantitation should be established as early as possible within the process. This work describes a gas chromatography area% method for the detection and quantitation of all regioisomer impurities associated with 3-chloro-5-fluorophenol, a raw material used within the pharmaceutical industry along with other related impurities found within 3-chloro-5-fluorophenol. Several method development aspects, as well as a general regioisomer impurity control strategy related to 3-chloro-5-fluorophenol are discussed.
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DOI:
10.4172/2157-7064.1000356