[Importance of dissolution profile in stability tests]. / A kioldódási profil jelentosége a stabilitási vizsgálatokban.
Acta Pharm Hung
; 77(2): 132-41, 2007.
Article
en Hu
| MEDLINE
| ID: mdl-17933273
ABSTRACT
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
/
Agua
Idioma:
Hu
Revista:
Acta Pharm Hung
Año:
2007
Tipo del documento:
Article