Characterization
From impurity identification to primary reference standards, our synthetic, organic and analytical chemists can assist with both routine and challenging characterization projects. We provide characterization services for drug substances, excipients, drug products, degradant impurities, process impurities and the evaluation of container closure systems.
Our GMP facilities contain the isolation and characterization capabilities of:
- Liquid/liquid and solid phase extraction
- Preparatory TLC
- Preparatory HPLC
- Flash chromatography
- Semi-preparatory liquid chromatography
- Preparatory chromatography
- Recrystallization
- Solid Phase Extraction (SPE)
- Semi-preparatory HPLC
- Radial chromatography
- NMR (31P, 19F, 15N, 1H and 13C)
- FTIR and HATR-IR
- MS and MS/MSn
- Assay (UV, HPLC, GC, CE and IC)
- Chromatographic purity (TLC, CE, HPLC and GLC)
- Metallurgical catalysts (ICP-MS, AA, AE)
- Moisture (KF, CKF)
- Thermal Studies (DSC and TGA)
- Inorganic ash (ROI, ICP, ICP-MS, AA)
- Reference Standard Quantification