Examinando por Materia "Fenómenos Químicos"

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    Análisis fisicoquímico en condiciones normales y de estabilidad acelerada de amoxicilina tabletas recubiertas de fiable y dudosa procedencia en el Cercado de Lima, diciembre de 2012
    (Universidad Privada Norbert Wiener, 2013) Santiago Valverde, Frank Eleazar; Torres Aguirre, Milagros Jacqueline; Chávez Fernández, Ana María
    The increasing commercialization of adulterated medicines and the lack of adequate regulatory control in the Peruvian pharmaceutical market represent a risk to patient health. This study aimed to contribute to the control and sanitary surveillance of amoxicillin film-coated tablets. Amoxicillin was selected as the study sample because it is classified as an essential medicine. Three main aspects were evaluated. First, the origin of the medicines was analyzed using checklists based on Supreme Decrees No. 014-2011/SA and No. 016-2011/SA. Second, the physicochemical properties of medicines from both reliable and questionable sources were assessed according to the Amoxicillin Tablets monograph and general chapters <905> and <1151> of the United States Pharmacopeia (USP 35). Third, the stability behavior of amoxicillin was evaluated under partial accelerated stability conditions following Health Directive No. 031-MINSA/DIGEMID. The results showed that the sample from a reliable source complied with all requirements of the Supreme Decrees. Questionable source samples 2 and 3 met the requirements of Supreme Decree No. 016-2011/SA, while sample 1 did not. Furthermore, the establishments from which questionable samples were collected failed to comply with Supreme Decree No. 014-2011/SA. All samples, however, complied with USP 35 acceptance criteria and the national directive regarding physicochemical quality and stability. In conclusion, although amoxicillin marketed in both pharmaceutical and non-pharmaceutical establishments met physicochemical quality standards and demonstrated stability under accelerated conditions, non-pharmaceutical establishments failed to comply with current Peruvian regulatory requirements.