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