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Revista Cubana de Plantas Medicinales

On-line version ISSN 1028-4796

Abstract

RODRIGUEZ LEYES, Eduardo A. et al. Accelerated stability study of D-004 active ingredient in different containers. Rev Cubana Plant Med [online]. 2009, vol.14, n.3, pp.54-60. ISSN 1028-4796.

INTRODUCTION: D-004 is a new active ingredient under research and development stage, which is obtained from Roystonea regia (Kunth) O. F. Cook fruits. OBJECTIVE: to precise over the D-004 stability under accelerated conditions in amber glass, polyethylene terephtalate and high density polyethylene containers. METHODS: samples from three batches were stored at (40 ± 2) ºC and (75 ± 5) % relative humidity for 12 months. Organoleptic characteristics, relative density, refractive index (USP 27) and fatty acids content by gas chromatography, were determined. RESULTS: measured parameters were within the set quality specifications , except for fatty acids content that significantly decreased in polyethylene terephtalate and high density polyethylene containers after 3, 4 and a half and 6 months, respectively. CONCLUSIONS: the amber glass protects more D-004 from degradation than the analyzed plastic containers.

Keywords : fatty acids; D-004; accelerated stability; Roystonea regia; polyethylene terephtalate; high density polyethylene, amber glass.

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