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Dissolution testing

For determination of the dissolution rate, a considerable quantity of equipment from various manufacturers is available in our equipment park. The equipment used includes Apparatus 1 (basket) and Apparatus 2 (paddle) in compliance with the requirements of the Ph. Eur. and USP.

Testing can be performed in both automated and manual form, allowing use of media that are difficult to automate, such as buffer solutions containing tensides or enzymes.

This allows routine testing of various dosage forms with conventional-release, prolonged-release or delayed-release of the active substance, even if there is a high sample throughput. This also applies to dissolution profiles, ranging from short-term profiles with 5-minute test times to long-term profiles with run-times of, e.g. 16 or 24 hours.

A well-practised team ensures smooth processing of the large sample quantities that occur with release and stability testing. This ensures rapid and high-quality execution, even of large-scale projects.

Through timely dissolution testing and prompt forwarding of the analysis results, we support our clients in both the daily routine and in pharmaceutical development.

We can, of course, also perform the desired dissolution under specific conditions, such as in our light-protected area using red or yellow light or in our laboratory for high-potency substances.

Method development and method validation

We develop and validate procedures for dissolution tests and analytical detection of substances to be assayed using HPLC, GC, UV/Vis spectrophotometric or titrimetric measurement.

In this area, we benefit from our many years of experience in validation for requirements within and outside the European area, such as validations for the Japanese regulatory area.

The work concludes with the compilation of a validation report that complies with regulatory requirements.