Laboratório de aplicação

ERWEKA & Quasaar Our Laboratory Services

ERWEKA expands its own tablet testing device portfolio with the pharmaceutical service offerings from Quasaar. Are you looking for comparative measurements and method transfers? Do you need a partner for method development and validation? Do you require dissolution studies under GMP conditions? Then we are your partner to take your pharmaceutical project to the next level.

Comparative Measurements & Method Transfer

Together with Quasaar, ERWEKA offers a range of services related to comparative measurements and method transfers – under GMP conditions and with the preparation of all relevant documentation.

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 & Validation

Method development is a complex process, and we can support you with it. We are also your partner for revalidation, optimization, and troubleshooting.

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

Do you require extensive dissolution studies, bioequivalence testing, or biopharmaceutical characterizations? We can help.

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

ERWEKA and Quasaar provide comprehensive advice on the laboratory equipment you need.

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

Learn more about our cooperation with Quasaar and the advantages it offers.

Press Release Quasaar Website