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vol.53 número2DEMOSTRACIÓN DE LA CONSISTENCIA DEL PROCESO DE FABRICACIÓN DE OLEOZON® ORAL MEDIANTE LA REVISIÓN DE LA CALIDAD DEL PRODUCTOCINCO AÑOS DE ESTUDIO DE ESTABILIDAD EN CURSO DE LAS TABLETAS DE POLICOSANOL (5, 10 Y 20 MG) EN BLÍSTERES índice de autoresíndice de materiabúsqueda de artículos
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Revista CENIC Ciencias Químicas

versión On-line ISSN 2221-2442

Resumen

SALAHANGE GONZALEZ, Laura et al. FATTY ALCOHOLS DETERMINATION BY GAS CHROMATOGRAPHY IN A NEW SKIN PROTECTIVE CREAM SUBMITTED TO STABILITY STUDIES. Rev. CENIC Cienc. Quím. [online]. 2022, vol.53, n.2, pp. 270-273.  Epub 15-Jul-2022. ISSN 2221-2442.

A new skin protective cream was recently developed containing the fatty alcohols 1-octacosanol (C28) and 1-triacontanol (30), which present antioxidant and anti-inflammatory properties. As part of the development of this new product, a Gas Chromatographic analytical method was validated. This method was used for the analyses of samples from three batches of the cream, which were submitted to accelerated stability assay during 12 months and to long-term stability assay during 36 months. The cream samples, packed at the rate of 25 g in lithographed aluminum tubes with inner epoxy-phenolic coating and high density polyethylene cap, were placed at 40 ( 2 (C and 75 ( 5 % relative humidity (accelerated stability), and at 30 ( 2 ºC and 70 ( 5 % relative humidity (long-term stability in climatic Zone IV). The validated analytical method allowed to demonstrate that the fatty alcohols content did not change during all the time in which the samples were analyzed, in both assays.Additionally, it was observed that during all the time, the creams kept their original organoleptic characteristics (semi-solid with a uniform appearance, without lumps or sandy consistency, with a white to light cream color and a characteristic odor), as well as their microbiological content and pH between the Quality Specification defined ranges. The results of the present study support that the cream resist 12 months in conditions of accelerated stability and 36 months when stored at the conditions of the climatic Zone IV.

Palabras clave : 1-triacontanol; 1-octacosanol; Gas Chromatography; skin protective cream; stability.

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