1. Estudios de estabilidad acelerados y a largo plazo de nuevos lotes industriales del ingrediente activo D002.
- Author
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Morales-Rico, Carmen Luisa, de la Caridad Sierra-Pérez, Roxana, González-Canavaciolo, Víctor Luis, Marrero-Delange, David, Vicente-Murillo, Roxana, and Rodríguez-Leyes, Eduardo Antonio
- Subjects
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FATTY alcohols , *BEESWAX , *ANTIOXIDANTS , *GAS chromatography , *TASTE testing of food , *THERAPEUTICS - Abstract
The D002, mixture of fatty alcohols (C24 - C34) extracted and purified from Apis mellifera beeswax, constitutes the active ingredient of Abexol® tablets, which have antioxidant and gastroprotective effects. The broadening of our exports to new markets has required the inclusion of new climate zones in the stability studies. In the present work the stability of three new industrial batches were studied under conditions of forced degradation, accelerated stability for 12 months (40 ºC and 75% RH) and long-term stability in climatic zones II and IV. The total alcohol content was determined by capillary gas chromatography, additionally losses on drying, organoleptic characteristics and formation of degradation products were determined. The results shown that under forced degradation conditions (acid and base hydrolysis, oxidation, thermolysis and photolysis) degradation products were not developed and alcohol contents were not affected. Otherwise, the accelerated and long-term studies also demonstrated the high stability of D002, since the alcohol contents and the other quality specifications were not affected. The results confirm a shelf life of at least three years, which is consistent with those reported in previous studies of stability of D002 and its manufactured forms. [ABSTRACT FROM AUTHOR]
- Published
- 2015