Analytical Services
CapEval Pharma can provide analytical strategies in accordance with ICH standards and develop approaches for pre-clincial and clinical product development.
We can help in the following areas:
Method development for API, impurities, genotoxic impurities
Development of validation protocols according to clinical phase or to ICH standards
Development of stability indicating methods
Impurities analysis -related substances, degradants and qualification
Reference standard qualification
Stability testing and data interpretation
Analytical method transfer and validation
Quality control
Setting specifications
Rapid bioanalysis – solid method development/sample analysis for complex approaches (e.g. cassette PK, tissue analysis)
GLP bioanalysis – method development/sample analysis under compliance with focus on ruggedness
Metabolite identification and bio-synthesis approaches
Specialities and Expertise:
Chromatographic separation (GC, HPLC, IC) and derivatization methods
ICP
Identification tests (NMR, IR, MS)
GC/MS and LC/MS technologies (triple quad, ion trap, TOF)
Genotoxic impurities
Polymorphic studies
Lipid analysis (total and free cholesterol, bile acids)
Isolation/characterization of metabolites using radiolabels