Identification of Pharmaceutical impurities typically involves impurities from multiple sources. Three of the most common sources are:
1) Process impurities from API or raw material
2) Degradation impurities from finished product
3) Leachable substances from container closures
With multiple Sciex Triple Quadrupole LC/MS/MS systems, our team of scientists can help our clients in the identification and structure elucidation of pharmaceutical impurities. Primera employs scientists with an organic chemistry education for our impurity studies.
Impurity identification can also be performed with our Thermo Q-Exactive Plus High Resolution Mass system (HRMS) for accurate mass and empirical formula determination.
With three preparative HPLC systems, Primera can isolate impurity peaks and collect fractions for further structure elucidation work such as NMR analysis and response factor determination.