Analytical Chemistry

Our experienced and dedicated team of analytical chemists utilize state-of-the-art instrumentation and expertise to generate the highest quality analytical data, supporting the resolution of complex challenges in drug discovery and development.

Covering standalone projects or as a part of our integrated chemistry offering, our analytical chemistry services ensure you can trust the quality of your compounds.

Structure elucidation and purification services

Our experience and state-of-the-art chromatographic and spectroscopic instrumentation enable the precise identification of molecules.

Using Mass Directed Auto-Purification, prep-HPLC and Supercritical Fluid Chromatography (SFC), our team can offer both chiral and non-chiral purifications to deliver between milligrams to multi-grams of compounds with the highest purity.

Our capabilities allow for the isolation of unknown compounds for impurity characterization, enhancing process chemistry understanding and fulfilling the strictest regulatory requirements.

Regulated analytical services – method development and validation

Our experienced team develops and maintains robust analytical methods throughout their lifecycle, following current guidelines (ICH Q14, USP <1220>) and ensuring method appropriateness for all drug discovery and development stages. We also perform forced degradation studies to ensure that developed methods are stability indicating whenever required.

The quality teams (QC and QA) collectively ensure that developed analytical methods are validated following ICH Q2 (R2) and USP <1225> guidelines, guaranteeing the suitability for their intended purpose.

We are able to guarantee drug quality, efficacy and safety during development programs by providing stability studies adhering to relevant ICH requirements and guidelines.

Physical characterization and elemental impurity analysis

Our specialized analytical team analyzes a variety of physical properties over a wide range of materials:

• Thermoanalytical capabilities (Differential Scanning Calorimetry - DSC), which are used to evaluate several physical properties such as: polymorphism, thermal stability and degradation susceptibility, melting points and glass transition
• Diffractometry analysis (X-Ray Diffraction - XRD) enabling for the identification of polymorphs and crystallinity analysis
• Wet and Dry Particle Size Distribution (PSD) analysis, ensuring that particle size – a critical factor for material and process performance – is controlled
• We guarantee that our products have safe levels of elemental impurities, using Inductively Coupled Plasma Optical Emission spectroscopy (ICP-OES) for analysis, following ICH Q3D guidelines