Analytics

Jesalis Pharma has proven experience in active ingredient and drug product analysis. In order to provide our customers with reliable results and expert opinion, the requisite equipment is available and GMP compliant.

Jesalis Pharma has a special expertise in the evaluation of the solid-phase properties of active ingredients and their influence on bioavailability and behaviour during formulation processes.

The main focus is

Method development and method validation (ICH)

  • API methods and methods for preformulations
  • drug formulation methods 
  • solid state characterisation methods

Solid-state investigation and evaluation of APIs

  • API solid-state characterisation
  • polymorphism / crystallinity investigation
  • investigation of aggregation and dispersion properties
  • trouble shooting for pharmaceutical manufacturers

Stability studies (ICH) planning, realisation and evaluation of

  • stress stability studies 
  • API and drug formulation long-term stability
  • interaction studies

API release analysis and quality decision (GMP)