Resumo

GARCIA PENA, Caridad Margarita; IRAIZOZ BARRIOS, Antonio  e  MARTINEZ ESPINOSA, Vivian. Study of stability of Risperidone (3 mg) tablets. Rev Cubana Farm [online]. 2010, vol.44, n.2, pp. 196-204. ISSN 1561-2988.

Stability study was conducted of 3 mg Risperidone tablets determining its caducity date and using the shelf life methods and of accelerated stability by high-performance liquid chromatography validated in Drug Development and Research Center. The shelf life study was developed during 24 months at room temperature; whereas the accelerated stability study was performed subjecting the product to light, humidity and temperature influence. The 3 mg Risperidone tablets formula fulfilled the quality specifications described in Pharmacopeia. Results from shelf life study after 24 months show that the product maintains the parameters determining its quality during that time and in accelerated studies product degradation was noted. Under conditions signaled 2 years was established as the expiry date.

Palavras-chave : Risperidone; accelerated stability; shelf life; high-performance liquid chromatography.

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