Analytical Development
Robust, Regulatory-Ready
Methods
Our analytical laboratory is equipped with a state-of-the-art array of orthogonal and complimentary analytical separation and detection methodologies.
Analytical Services and Capabilities
Liquid Chromatography
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HPLC, (U)HPLC, and UPLC
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LC-MS and LC-MS/MS with ESI, APCI, and DUIS interface
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Reverse Phase, Normal Phase, Ion Exchange, Size Exclusion, and Supercritical Fluid Chromatography (SFC)
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Chiral Separations
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Evaporative Light Scattering Detection (ELSD)
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Charged Aerosol Detection (CAD)
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Fluorescence Detection
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Refractive Index Detection
Gas Chromatography
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GC-FID with headspace and direct injection sampling
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GC-MS
Material Characterization
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400 MHz NMR, with 1D, 2D homonuclear and heteronuclear capabilities
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Dissolution (Apparatus I and II)
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ATR-FTIR Spectroscopy
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UV-Vis Spectroscopy
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X-ray Powder Diffraction
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Differential Scanning Calorimetry (DSC)
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Thermogravimetric Analysis (TGA)
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Particle Size Distribution (PSD)
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Water Content by Karl Fischer Titration (KF)
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Potentiometric Titration
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Polarized Light Microscopy (PLM)
Analytical Services
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Method Development
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GMP Method Validation
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ICH Stability Program Management
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Materials Characterization for IND 3.2.S.3 and 3.2.S.5
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Forced Degradation and Degradant Identification
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Pre-formulation Developability Assessment
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Solubility and Stability Assessment
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Polymorph and Salt Screening
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Potential Mutagenic Impurities / Potential Genotoxic Impurities (PMI/PGI)
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In-process Control
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Process and Formulation Development Support
ICH Stability Chambers
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25°C/60% RH
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30°C/65% RH
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40°C/75% RH
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2-8°C/ambient
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-20°C/ambient
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-80°C/ambient
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ICH Q1B UV and Visible Photostability