Dissolution Excellence

Benefit from the combined expertise of two “Excellence Partners” for dissolution! Erweka and Quasaar have been collaborating since 2025, offering a synergistic portfolio in the field of drug release testing. From method development, customization, and equipment qualification to the execution of complex studies, we provide comprehensive, end-to-end support. What do we need from you? Simply the project goal — we will take care of the rest. Our experts provide consulting across all relevant areas and work with you to create an efficient, solution-oriented study plan. Whether dealing with new active ingredients, formulations, innovative dosage forms, or sophisticated release concepts, we develop a solution aimed at creating a routine-ready release method that can be operated using standard equipment. Subsequently, we validate the methods and transfer them to your regulated environment or conduct the testing in our GMP- and FDA-qualified laboratory facilities

Service Portfolio: Erweka-Quasaar Partnership

Comparative measurements and method transfer:

  • Performance comparison of dissolution apparatus from different manufacturers and models
  • Preliminary studies or formal method transfer under GMP conditions
  • Experienced laboratory team provides on-site support and training if required
  • Preparation of all relevant GMP documents and SOPs

Method development and validation:

  • Complete development of dissolution methods from solubility testing and selection of apparatus type to definition of method parameters and demonstration of discriminatory power
  • Development and validation of analytical methods for dissolution evaluation (e.g., U-HPLC, photometry), including full documentation
  • Revalidation of methods following changes to method parameters (e.g., filters, sinkers, media, concentration range, formulation, etc.)
  • Feasibility assessment for transitioning manual methods to automation (including validation)
  • Optimization of dissolution methods (duration, media, robustness, etc.)
  • Troubleshooting of dissolution methods
  • Creation of test specifications and SOPs

Dissolution studies:

  • Determination of dissolution behavior for quality control and stability studies under GMP (including CoA or result report)
  • Execution of profile dissolution studies in various media / pH values
  • Bioequivalence testing via dissolution comparison of originator and comparator products (including SUPAC studies)
  • Biopharmaceutical characterization of formulations
  • Special dissolution testing: gastric resistance, buffer transitions, enzyme addition, infinity test, intrinsic dissolution, simulation media, influence of food, alcohol, stress conditions, etc.

Device support:

  • Design of customized dissolution apparatus for special dosage forms
  • Design of specific adapters
  • Adjustment and extension of relevant device parameters (temperature, volume, rotation speed, etc.)
  • Provision and execution of qualification concepts
  • On-site support by an experienced technical team

Need more details about our partner ERWEKA? Follow the link to their website!