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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515versión On-line ISSN 1561-2988

Resumen

VALDES BENDOYRO, María Olga; GARCIA PENA, Caridad Margarita; LUGONES FERNANDEZ, Juan  y  MARTINEZ ESPINOSA, Vivian. Study of the 50 mg Propylthiouracil tablets stability. Rev Cubana Farm [online]. 2010, vol.44, n.1, pp.30-36. ISSN 0034-7515.

Autors developed a stability study of 50 mg Propylthiouracil tablets and determination of its expiry date. This study was conducted by fixed life methods and of accelerated stability by high-performance liquid chromatography, validated in Drugs Research and Development Center. Fixed life study was conducted during 24 months at room temperature; whereas the accelerated stability study was conducted exposing the product to light influence, humidity and temperature; during 3 months a analysis was performed for the two first ones and over 6 months in the case of temperature study. Propylthiouracil formula (50 mg tablets) fulfilled the quality specifications described in Pharmacopeia. Results of stability study by fixed life after 24 monhts showed that thr product maintain the parameter determining its quality during this period, and in the accelerted studies there was not a significant degradation of product. Two years was the expity date established in above mentioned conditions.

Palabras clave : Propylthiouracil; accelerated stability; fixed life; high-performance liquid chromatography.

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