Whether it is for routine analytical release testing or the development of challenging or specialized analytical methods for your large or small molecule, Dalton’s team of highly experienced analytical chemists use up-to-date, compliant laboratory infrastructure to meet your quality standards. By integrating analytical method development and validation services with API and dosage form manufacturing, we reduce turnaround times for your drug development program and achieve key milestones faster.
Raleigh Molecular’s comprehensive analytical services support our integrated services including drug discovery, drug development , process development, contract cGMP API synthesis, and cGMP finished dose manufacturing. Our on-site microbiology services lab is part of our complete analytical service offering.
Our Raleigh Molecular Analytical Services division was strategically designed to accommodate a diverse range of analytical tools. This lab is integral to our cGMP manufacturing services, offering support for analytical method development, method validations, testing for raw materials, in-process analysis, final product release testing, and stability evaluations. Raleigh Molecular employs state-of-the-art industry-standard equipment such as HPLC, GC, LC-MS, SEC-MALS, KF titration, among others, to meet our customers’ needs.
Our contract analytical laboratory services encompass:
– Analytical Development Services
– Accelerated Stability Testing & Storage Services
– Flow Chemistry
– SEC-MALS
– ICP-MS Elemental Analysis
– UPLC Analysis
– Extractables and Leachables Testing Services
– Microbiology Services
– Chiral analysis (HPLC and GC) and preparative HPLC chiral chromatographic separations for comprehensive characterization of pharmaceutical, biopharmaceutical, and synthetic chiral compounds
– Raw Material / Finished Product Testing (including cytotoxic materials)
– Certification of Reference Standards
– Physical and Wet Chemical Analysis
– Process and Cleaning Validations
– Container / Packaging Testing
– Thin Layer Chromatography (TLC)
– Organic Volatile Impurities (OVI)
– Arsenic Analysis
– Melting Point Determination
– Residue on Ignition (ROI)
– Loss on Drying (LOD)
– Elemental Analysis (EA)
– Polymorphism Screening
Here are some of the analytical instruments we utilize for both large and small molecule analysis:
– LC-MS (Liquid chromatography mass spectrometry)
– LCQ Classic
– LCQ Duo with Electrospray Ionizer (ESI)
– LCQ Deca
– HPLC
– DAD – Diode Array Detector (UV)
– Variable Wavelength UV Detector
– Conductivity Detection
– Fluorescence Detection
– Evaporative Light Scattering Detection (ELSD)
– SEC-MALS
– GC (Gas Chromatography)
– Flame Ionization Detector (FID)
– Thermal Conductivity Detector (TCD)
– Headspace techniques (USP-OVI)
– Spectroscopy UV / Visible
– Infrared (FTIR)
– Particle Size Analysis
– Polarimetry
– Osmolality
– Oxygen Headspace Analyzer
– Differential Scanning Calorimetry (DSC)
– KF (Volumetric & Coulometric)
– pH Measurements
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