Non-Volatile Organic Impurities
Identify and quantify organic impurities in drug substances and drug products
Impurity profiling is a critical quality control step in the production of pharmceuticals and biopharmaceuticals. This process is carefully regulated by bodies such as ICH & US FDA. ICH guidelines for impurities states that each impurity must be investigated with respect to both physicochemical and safety aspects. Structural characterization, quantification and reporting must be performed using suitable analytical procedures. Impurity profiling of organic impurities is typically performed using liquid chromatography (HPLC), mass spectrometry (MS) and nuclear magnetic resonance spectroscopy (NMR).
Confident, unambiguous elemental composition and substructural information can be provided by our Orbitrap-based mass spectrometry systems, together with advanced informatics capabilities and libraries.
Non-volatile organic impurity profiling workflow
Get increased separation speed and resolution using the Thermo Scientific Vanquish UHPLC system with the ability to detect and quantify virtually any substance using the near-universal detection capabilities of Thermo Scientific Vanquish UHPLC Charged Aerosol Detectors. With enhanced linear dynamic range and accurate, consistent response, this detector can measure low-level impurities and active pharmaceutical ingredients (APIs) simultaneously, as well as other compounds, regardless of chemical structure.
Save time identifying unknown organic impurities using Compound Discoverer software. This software ensures confident, unambiguous compound identification and structural elucidation for pharmaceutical impurity studies. Compound Discoverer software helps researchers plan how data will be collected, organized, stored, and reported with the final result in mind. Its node-assembled processing workflows, advanced algorithms, and study-oriented data storage allow users to quickly process and assemble data collected from multiple samples into a unified report.
mzCloud™ from HighChem is a scientifically solid and computationally robust platform for the identification of small molecules using tandem mass spectrometry (MS). It comprises curated databases of high- and low-resolution MSn spectra acquired under a number of experimental conditions. Interrogate a freely searchable collection of spectra, spectral trees, structures, fragments, precursor ions, chromatographic data and compound related references through a web-based interface providing a number of search, visualization and data processing tools.
The Thermo Scientific Q Exactive Hybrid Quadrupole-Orbitrap Mass Spectrometer introduced the revolutionary concept of Quanfirmation - combined Quantification and Confirmation. The Q Exactive Plus Hybrid Quadrupole-Orbitrap Mass Spectrometer takes impurity profiling to the next level with increased performance and new options that enhance screening studies.