BRIEFLY EXPLAINED
Dissolution testing
For dissolution testing, we have a wide range of (high-end) laboratory equipment from different manufacturers, including “basket” and “paddle” apparatus, “rotating cylinders” for testing of patches, and special equipment specified in some monographs. We also benefit from our many years of experience in validation concerning requirements outside of Europe (e.g. Japanese area of application).
The tests can be carried out both automatically and manually. The use of buffer solutions containing surfactants or enzymes is also possible.
Under these conditions, different dosage forms can be analyzed with unchanged, prolonged or delayed release of active pharmaceutical ingredients, even with high sample throughput. This also applies to dissolution profiles – ranging from short-term profiles with five-minute samples to long-term profiles with run times of up to 24 hours.
In addition, we develop and validate methods for dissolution testing and analytical detection of the active pharmaceutical ingredients to be determined using HPLC, GC, UV/Vis spectrophotometric or titrimetric measurement.
Our unique strength lies in our long-standing teamwork. This provides the basis for the precise completion of even extensive projects in a short time and guarantees a smooth workflow even with high sample volumes. Whether in daily routine operations or development of pharmaceutical methods, the rapid transmission of our analytical results enables us to maintain our customers’ workflow at every stage.
Of course, on demand we also provide dissolution testing under specific conditions: e.g. within our light protected area lighted with red or yellow light or in our laboratory for highly active substances.
