The aim of stability testing lies in its possibility of revealing all the effects that may influence the quality, efficacy and safety of a pharmaceutical preparation. The stability of a dosage form means that the release of the active ingredients remains unchanged or within specific limits. The manner of stability testing is regulated by guidelines, which consist of- besides the regular tests of the active ingredient and the degradation products, the concerning impurities, the water content, the hardness - the dissolution tests. Most physical changes influence the drug release in vivo, which can - in vitro - be followed by dissolution.
|Translated title of the contribution||Importance of dissolution profile in stability tests|
|Number of pages||10|
|Journal||Acta pharmaceutica Hungarica|
|Publication status||Published - Aug 24 2007|
ASJC Scopus subject areas
- Pharmaceutical Science