Analytical Chemistry
Our analytical services are built to support the evolving demands of early-stage drug development. From developing stability-indicating methods to profiling impurities and characterizing complex formulations, we apply rigorous science and state-of-the-art instrumentation to generate high-quality data that moves your compound forward with confidence.
Analytical Method Development & Optimization
Phase-appropriate method development and optimization to support drug substance and product testing across early development.
Includes:
High-resolution LC-MS/MS, HPLC, and UV method development & validation
Assay, purity, and content uniformity
Method troubleshooting and phase-appropriate optimization
Reverse Engineering of Drug Products
Analytical deconstruction of generic or commercial products to support 505(b)(2) or ANDA strategy.
Includes:
Identification and quantification of APIs and excipients
Dosage form and delivery system analysis
Comparative profiling for formulation development
Impurity & Stability Profiling
Comprehensive impurity and stability testing to assess drug degradation pathways and ensure formulation robustness.
Includes:
Forced degradation under ICH conditions
Stability-indicating method development
Impurity identification and quantification
Accelerated and solution stability studies
Structural & Mass Spectrometry Analysis
Advanced mass spectrometry for structural confirmation, impurity ID, and metabolite analysis.
Includes:
High-resolution mass spectroscopy
Molecular weight and formula confirmation
Structural elucidation of unknowns
Analytical Expertise
We bring deep technical expertise to a range of challenging analytical problems often encountered in early drug development.
Broad experience with small molecules, proteins, RNA, and natural products
High-throughput analytical workflows designed to support early screening and rapidly assess large compound libraries
Fast-turnaround methods (1–3 minute runtimes) to accelerate decision-making
Chiral separation techniques to resolve enantiomers and support stereochemical analysis
CAD detection for analytes lacking UV chromophores
Custom solutions for low-solubility, low-dosage, and complex formulations