Overview
The manufacturing of a pharmaceutical product results in the accumulation of impurities from a variety of sources. Pharmaceutical regulatory agencies require that an impurity profiling testing method is utilized to ensure that the amount of impurities is below an allowable limit. As demonstrated below, a high performance core-shell Kinetex EVO C18 column obtains narrow peak shape and extremely useful resolution for a doxylamine formulation impurity profile. Unlike traditional fully porous and core-shell products, the pH 1-12 stability of the EVO C18 material allows this method to utilize a high pH mobile phase that aids in retention and separation. More so, the sharp, narrow peak shape means that more accurate quantification and therefore more reliable data is obtained.
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