Analytical Testing Services
Chromatogen Analytical Laboratory provides comprehensive, high-resolution analytical testing services designed to meet the rigorous demands of the pharmaceutical, chemical, and allied industries. Utilizing state-of-the-art instrumentation and validated protocols, our expert scientific team delivers precise, trace-level quantification, structural elucidation, and regulatory-grade data to accelerate your R&D and manufacturing timelines.
Core Testing Capabilities
We offer an array of advanced testing methodologies tailored to complex matrices, synthetic compounds, and raw materials.
1. High-Resolution Mass Spectrometry (HRMS)
Unknown Impurity Profiling: Detection, isolation, and identification of trace-level impurities and degradants.
Structural Elucidation: Definitive molecular weight determination and elemental composition verification for novel APIs, synthetic intermediates, and complex organic molecules.
Trace Analysis: High-sensitivity quantification of genotoxic impurities, nitrosamines, and extractables/leachables.
2. Chromatographic Analysis (LC & GC)
High-Performance Liquid Chromatography (HPLC / UHPLC): Equipped with diverse detection capabilities (DAD, ELSD, MS) for assay validation, purity determination, and related substances testing.
Gas Chromatography (GC): Advanced GC-FID and Headspace GC configurations optimized for residual solvent analysis, volatile organic compounds (VOCs), and reaction monitoring.
Chiral Analysis: Rapid resolution and quantification of enantiomers and optical isomers using specialized chiral stationary phases.
3. Spectroscopy & Physical Characterization
Nuclear Magnetic Resonance (NMR) Services: Structural confirmation, conformational analysis, and complex mixture profiling.
Spectrophotometric Testing: UV-Vis and FTIR analysis for structural fingerprinting, functional group identification, and raw material qualification.
Industry Applications
Our analytical testing infrastructure is built to support diverse sectors throughout their product lifecycles:
Pharmaceuticals & Biopharma: Characterization of Active Pharmaceutical Ingredients (APIs), key starting materials (KSMs), final drug products, and stability testing support.
Specialty & Fine Chemicals: Quality assurance, composition verification, and purity certified reporting for high-value chemical synthesized batches.
Process R&D Support: Fast turnaround testing for route scouting, reaction kinetics monitoring, and material characterization before scaling up to CDMO facilities.
The Chromatogen Advantage
Uncompromising Accuracy. Industry-Standard Compliance.
At Chromatogen, we combine advanced instrumentation with deep scientific expertise. Our testing workflows ensure rapid sample throughput without sacrificing the high resolution and data integrity required for critical regulatory filings and technical transfers.