Pharmaceutical
Primera specializes in customized analytical method development using state-of-the-art analytical tools, and understands the unique needs of our customers. Our technical know-how and extensive experience with organic and inorganic compounds, as well as biochemicals, allows us to develop sensitive analytical methods to identify and quantitate bioactive substances, chemical and biochemical substances, impurities, degradants, and preservatives in a wide range of test matrices for product and stability assessment. We are registered with the FDA (no observations and no 483 findings from the last FDA audit, 10/2008) and are in full compliance with GLP/cGMP regulations.
Capabilities
- Stability studies (Temp/RH/Light), ICH or other conditions
- Leachables and Extractables
- Chiral separation
- Drug substance impurity profiles
- Pre-clinical and clinical studies
- Coulometeric and volumetric Karl Fischer testing
- Coulometeric metal analysis
- Polymer analysis
- Full sample management service
- Residual Solvents
- Raw materials, API, finished products, dosing solutions
- Formulation matrix
- Blood, serum, urine, and tissues
Major Analytical Instrumentation
- HPLC and LC/MS/MS
- ICP-MS
- Dissolution
- GC and GC/MS
- GPC/SEC
- IC and CE/CZE
- Spectrometer (UV, Fluorescence)
- FT-IR