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Revista Cubana de Farmacia
versão On-line ISSN 1561-2988
Resumo
GARCIA PENA, Caridad M. et al. Study on stability of Clonazepam tablets (2 mg) without lactose. Rev Cubana Farm [online]. 2007, vol.41, n.2, pp. 0-0. ISSN 1561-2988.
Study of 2 mg Clonazepam tablets without lactose was performed, and due date was determined. This study was performed by support-life method and accelerated stability by high-performance liquid chromatography, developed and validated in Drugs Research and Development Center. Support-life study was developted during 24 months to a room-temperature; whereas accelerated stability study as performed with product undergoes light, humidity, and temperature. Analysis was carried out during 3 months for two above first, and during 6 months for temperature-study. Formulation of 2 mg tablets Clonazepam meets quality specifications described in Pharmacopeia. Results of stability study for support-life after 24 months, showed that product maintains parameters determining its quality during that period, and in accelerated studies there wasn’t a significant degradation of product. Two years are stablished as due date in above mentioned conditions.
Palavras-chave : Clonazepam; accelerated study,; support-life; high-performance liquid chromatography.