Structural determination

As a general rule, impurities present at concentrations reaching 0.1 % must be chemically identified, as stated in the internationally harmonized ICH guides (Q3A and Q3B).

Nowadays, Mass Spectrometry has become a popular and advantageous technique for chemical identification of unidentified detected impurities because of its selectivity, sensitivity, and compatibility with HPLC-UV.

Structural elucidation and confirmation of impurities is appropriately and profitably addressed with our AB Sciex 5600 Triple TOF mass spectrometer that provides structural information about fragments, empirical formula and accurate molecular weight of the impurity molecule. This enables our mass spectrometry highly-skilled scientists the unambiguous confirmation of the identity of any chromatographic peak present in the HPLC-UV profile, matching the high resolution mass spectra of standards of hypothesized molecules after analysis of the MS data of the impurity.

Structural determination