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- W2161566211 abstract "D-004 is a new active ingredient obtained from the Cuban royal palm (Roystonea regia) fruits. This sub- stance is mainly composed by a mixture of saturated and unsaturated free fatty acids, from 8 to 18 carbon atoms, and has shown to be effective in experimental model of prostate hyperplasia. A capillary gas chromatographic method for the determination of the fatty acids in D-004 was developed and validated. The acids were analyzed as methyl ester deriva- tives, which were obtained by reaction with 10 % acetyl chloride in methanol and separated in a BPX-5 wide-bore column using tridecanoic acid as internal standard. The specificity study showed no interferences regarding the determination of this mixture, once the samples were submitted to stress conditions. Determination of the total fatty acid content was linear (r > 0.999; CVs of the response factors and of the slopes lower than 5 and 2 %, respectively) and without bias in the studied concentration range, from 50 to 150 % of the nominal mass. In the accuracy study, over the range 80 to 120 % of the nominal fatty acid concentration, high recoveries (100.4 to 100.8 %) were reached. Good results were obtained in the repeat- ability and intermediate precision studies (CV < 2 %), proving that the method is precise. These results support that this method is properly validated, being appropriate for the quality control and stability studies of this active ingredient." @default.
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- W2161566211 date "2009-01-01" @default.
- W2161566211 modified "2023-10-17" @default.
- W2161566211 title "Validación de un método por Cromatografía de Gases para la determinación de los ácidos grasos que componen el D-004 ingrediente activo" @default.
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