Method Development for Drug Impurity Profiling: Part 1

Dejaegher, Bieke; Dumarey, Melanie; Heyden, Yvan Vander
April 2010
LC-GC Europe;Apr2010, Vol. 23 Issue 4, p218
Trade Publication
In this Practical Data Handling column, method development for drug impurity profiling is discussed. This first part consists of the first two steps when developing a drug impurity profile: the selection of a suitable chromatographic column and the optimization of the mobile phase pH. Prior to the impurity profiling, the selection of a set of dissimilar chromatographic columns is made (i.e., columns with different selectivities) to be screened with the impurity mixture for selectivity differences.


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