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Dissolution testings are often part of stability studies. The path to performing these routine tests is often a long and arduous one, starting with the qualification of the testing equipment to the development and analytical validation of the relevant methods.
Particularly for modified release formulations, the usage of automatic dissolution systems is considered obligatory. At all stages, particular attention has to be paid to the relevant guidelines.
An article by Sandra Vierkoetter – published in the journal “Chemische Rundschau” 10/ 2009 – describes the general principles of dissolution apparatus and their qualification as well as ideas on method development and validation of dissolution procedures.
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