ANALYTICAL SERVICES INCLUDE: • Full chemical USP/NF compendial testing • Raw material testing • Final product release testing • Stability studies in compliance with ICH guidelines • Stability indicating methods • Impurity and degradation product identification • Forced degradation studies • Assay identification • Reference standard qualification • Dissolution • Method validation • Method transfer • Customized contract projects MAJOR INSTRUMENTATION CAPABILITIES: • High Performance Liquid Chromatography • HPLC HP 1100 • HPLC HP 1050 • Photo Diode Array and VWD detectors • Chemstation / Chemstore Software • High Performance Gas Chromatography • GC 6890N • G1888 Network Headspace Sampler • Chemstation / Chemstore Software • FT-IR - Perkin Elmer Spectrum One Spectrometer with Spectrum ES v.5.2 Software • UV/Vis - Hewlett Packard 8452A Diode Array Spectrophotometer with Chemstation Software • Dissolution Test Stations • Hanson Research SR8 PLUS • Vankel VK7025 • Thermo Forma Stability Chambers • 25ºC/ 60% RH • 40ºC/ 75% RH • Fully mapped (empty & full) for both temperature and humidity to ensure temperature and humidity uniformity. • Titrators • Karl Fisher DL38 • Potentiometric Titrator T-50