Chromicent

• Method development according to quality by design

  Chromicent always develops methods using a risk- and science-based Quality-by-Design approach with a view to the complete life cycle of a method. Chromicent's methods are robust, user-oriented, designed for routine analysis, easy to transfer to any laboratory, time and cost efficient and take into account environmental and safety aspects.

• Troubleshooting of existing methods

Established methods are often ineffective, slow or not robust enough, leading frequently to method related out-of-specification results (OOS). Chromicent supports the optimization of existing methods by robustness testing in the course of risk assessment, determination of the variation ranges as well as checking all areas of validation.

• Genotoxic impurities (GTI)

Chromicent has developed its own methods for testing genotoxic impurities in drug substances and products, including nitrosamines in Sartans (valsartan, losartan, irbesartan). Our analysis using SFC-MS/MS includes eight further nitrosamines in addition to the NDMA and NDEA, most of which are known to be problematic. Methods for the detection of pyrrolizidine alkaloids in medicinal plants are in preparation.

• Impurity Profiling

Impurity profiling and forced degradation studies as well as stability and photostability testing of drug substances and drug products to establish the degradation pathways and to prove stability of the molecule incl. mass balance and to validate the stability indicating power of the method use.

The equipment of Chromicents laboratories includes, among others: HPLC and UPLC systems with PDA-, UV-, RI-, ELS-, FL and charged aerosol detection as well as with single and tandem MS detection, bioinert UHPLC system especially for large molecules, Ultra-Performance SFC system with PDA- and tandem MS detection, preparative LC system with fraction collector, ion chromatograph, dissolution tester with manual and automatic sampling and comprehensive sample preparation equipment.