Doxylamine Impurity Profile Using a Kinetex EVO C18 Core-Shell LC Column

Abstract:

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.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Kinetex

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