Analytical development

Analytical development at HFR runs in parallel with synthetic progress, ensuring that as processes evolve, quality and consistency are never compromised. By anticipating changes to impurity profiles and adapting methods accordingly, we keep projects on a reliable path toward manufacturing readiness.

Understanding and controlling impurities

Impurity profiling is critical to product performance. We carry out risk assessments across the process to identify, quantify and control impurities, whether they are by-products of synthesis or residues from solvents and catalysts. This allows us to define clear specifications for intermediates and final products.

Method development and validation
Our team has extensive experience in developing methods for assay and impurity analysis. These methods are validated to ICH standards before GMP manufacture, ensuring they are robust enough to support both regulatory requirements and long-term use in production.

Stability studies
To guarantee safe, effective manufacture, we conduct both accelerated and long-term stability studies to ICH guidelines. These studies provide insight into optimal storage conditions and shelf life, using proof-of-concept or validation batches representative of future manufacture.

Analytical development at HFR brings clarity and confidence, giving every project a stronger foundation for successful scale-up and commercialisation.