| Testing products for assay, related
substances, uniformity of dosage, dissolution and physical parameters for
in-process and finished products. Support group for various testing
levels including dissolution profiles, process validation and cleaning
validation.
Raw Materials
Testing bulk actives and excipients for purity and conformity to USP/NF or other compendia.
Stability Program Management
Testing
products that are on a stability program, utilizing ICH guidelines for assay, related substances, dissolution, and physical parameters.
Analytical Support
Method transfer, method design and development, and validation for testing products.
Laboratory Equipment Includes:
- High Pressure Liquid Chromotography Systems including diode array detection (Perkin Elmer, Waters, Hewlett-Packard, Beckman)
- Gas Chromatographs with Headspace Analyzer (Perkin Elmer)
- UV-Visible Spectrophotometers (Hewlett-Packard)
- USP Dissolution Systems (Hanson, Distek, Vankel)
- Zymark Robotic Tablet Processing Workstation
- USP Disintegration Apparati
- Hardness Tester (VanKel)
- FT-IR Spectrometer (Analect, Nicolet)
- Polarimeter
- Alpine Airjet Sieve
- Rotap Sieve Shaker
- Tap Density Tester (VanKel)
- Sievers Total Organic Carbon Water Analyzer
- Moisture Analysis (Karl
Fisher/LOD)
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