|
Analytical and Bioanalytical Services |
|
For analytical and bioanalytical services we utilize a state-of-the-art Instrumentation Suite and support a large variety of tasks in medicinal chemistry, process development, drug formulation, preclinical and clinical drug development, and quality control of the raw ingredients. To request any of our services for your samples please download the following NAT Analytical Services Submission Form.
NAT Analytical and Bioanalytical Services include:
- Chromatographic separation and quantitation of major and minor components in raw API and formulated drug products.
- Identification of new impurities generated during manufacturing, stress testing and stability studies.
- Analytical support for the design, synthesis, and scale-up of new chemical entities.
- Development of qualitative and quantitative analytical HPLC, LC/MS or LC-MS/MS methods of small molecule drugs in support of preclinical drug discovery studies.
- Acquisition, processing and reporting pre-clinical and pharmacokinetic and toxicokinetic data, including ADME, protein binding and metabolites identification.
- Development of qualitative and quantitative bioanalytical LC-MS/MS methods (Applied Biosystems/MDS SCIEX API 4000 triple quadrupole mass spectrometer) of small molecule drugs and metabolites in biological matrices (plasma, urine, and various tissues).
- Analytical support for pharmacokinetics studies, dose formulation and dose verification, metabolite identification, stability, solubility, and other experimental needs.
- Development of small molecule extraction protocols for various biological matrices using liquid-liquid extraction (LLE), solid phase extraction (SPE) and protein precipitation techniques.
- PK data generation and interpretation for non-compartmental analysis using WinNonlin software.
- 96-well sample processing and analysis.
|