Raw Material and Drug Product Testing
We provide comprehensive analytical capabilities for the on-site release testing of raw materials used to manufacture your products. All work is done in compliance with current cGMP.
Our raw material testing capabilities include:
- Compendia testing (USP/NF, EP, BP, JP, FCC, AOAC) on an extensive range of materials with strict adherence to the requirements of the procedures used from each standard reference
- Numerous traditional wet chemistry techniques including, but not limited to: titrimetry, fats and fixed oils tests (e.g. saponification, iodine, and hydroxyl values), as well as USP General Identification tests
- Chromatography, including various preparation and detection techniques for HPLC, GC, IC and TLC testing
- Heavy metals quantificaiton at pharmacopoeial acceptance limits by ICP
- Ion chromatography for fast and accurate cation and anion identificaiton
- Loss on drying and residue on ignition including Sulphated Ash
- Direct (volumetric) and indirect (Coulometric) Karl Fischer water content analyses
- Kjeldahl nitrogen testing
- Organic Volatile Impurities methods
- FTIR
- Conductimetry and Potentiometry
- Specific rotation
- Specific gravity
- Capillary and rotational instrument viscosity determinations
In addition, we can perform additional analytical procedures that are required in the various compendia. These techniques include, but are not limited to, Atomic Absorption (AA), Near Infrared (NIR), Nuclear Magnetic Resonance (NMR), and Microscopy.