Investigations on an analytical artifact caused by in-column degradation of an NCE during assay and impurity content analysis by HPLC
During assay and impurity testing of a New Chemical Entity (NCE) and related products, atypical chromatograms were generated where a new peak was suddenly detected applying a validated HPLC method, which had been successfully used for several months. The new peak was not consistently present in different analytical sequences run with the same method on different days and analysis set-ups.
However, when present, the peak was observed in the same amount in chromatograms of different API samples. An investigation was raised to confirm if the peak was an impurity present in the API, or instead generated during the chromatographic analysis, and therefore not present in the API. The scope of the investigation included identifying the root cause in order to avoid the presence of this peak in the future.
Recently presented at AAPS 2017 by our expert, Paola Bisol, in collaboration with Neurocrine Biosciences, download your copy of this poster now and discover more!