Calidad fisicoquímica del producto terminado Dextrometorfano bromhidrato 15mg/5mL jarabe de un laboratorio farmacéutico nacional
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre-profesionales tuvo por objetivo determinar la calidad fisicoquímica del producto terminado Dextrometorfano bromhidrato 15 mg/ 5 mL jarabe de un laboratorio farmacéutico nacional. Para lo cual se trabajó con la técnica analítica del laboratorio basada en las especificaciones establecidas por la monografía oficial “Farmacopea de los Estados Unidos USP 42”. Se empleó una muestra de estudio de 16 frascos de un lote, según el procedimiento de muestreo correspondiente a producto terminado destinado al área de control de calidad fisicoquímico. Los ensayos fisicoquímicos evaluados fueron: aspecto, volumen de entrega, peso específico, pH, identificación y valoración. Los resultados obtenidos fueron: solución de color rojo, sabor amargo ligeramente dulce, olor a fresa; el volumen de entrega fue de 123 mL/Fco; peso específico 1.0605, pH 5.5, en la identificación de dextrometorfano bromhidrato por rotación óptica la solución es dextrógira ,por reacción de color con nitrato mercúrico no se produce un color rojo inmediatamente, pero, después de calentar, se desarrolla un color amarillo a rojo en aproximadamente 15 minutos; el ensayo de valoración presento un valor promedio de 14.90 mg/5mL (99.3%). Por lo tanto, se concluye que el producto terminado Dextrometorfano bromhidrato 15 mg/ 5 mL jarabe cumple con las especificaciones técnicas establecidas por la USP 42.
ABSTRACT The present report of pre-professional practices was to determine the physicochemical quality of the finished product Dextromethorphan hydrobromide 15 mg/ 5 mL syrup from a national pharmaceutical laboratory. For which we worked with the laboratory analytical technique, based on the specifications established by the official monograph " United States Pharmacopeia USP 42". A study sample of 16 bottles from a lot was used according to the sampling procedure corresponding to the finished product destined for the physical-chemical quality control area. The physicochemical tests evaluated were: appearance, delivery volume, specific weight, pH, identification and assessment. The results obtained were: red solution, slightly sweet bitter taste, strawberry smell; delivery volume was 123 mL/Fco; specific weight 1.0605, pH 5.5, in the identification Dextromethorphan hydrobromide by optical rotation the solution is dextrorotatory, by color reaction with mercuric nitrate a red color is not produced immediately, but, after heating, a yellow to red color develops in about 15 minutes, as obtained in the assessment; the evaluation test presented an average value of 14.90 mg/5mL (99.3%). Therefore, it is concluded that the finished product Dextromethorphan hydrobromide 15 mg/ 5 mL syrup complies with the technical specifications established by USP 42.
ABSTRACT The present report of pre-professional practices was to determine the physicochemical quality of the finished product Dextromethorphan hydrobromide 15 mg/ 5 mL syrup from a national pharmaceutical laboratory. For which we worked with the laboratory analytical technique, based on the specifications established by the official monograph " United States Pharmacopeia USP 42". A study sample of 16 bottles from a lot was used according to the sampling procedure corresponding to the finished product destined for the physical-chemical quality control area. The physicochemical tests evaluated were: appearance, delivery volume, specific weight, pH, identification and assessment. The results obtained were: red solution, slightly sweet bitter taste, strawberry smell; delivery volume was 123 mL/Fco; specific weight 1.0605, pH 5.5, in the identification Dextromethorphan hydrobromide by optical rotation the solution is dextrorotatory, by color reaction with mercuric nitrate a red color is not produced immediately, but, after heating, a yellow to red color develops in about 15 minutes, as obtained in the assessment; the evaluation test presented an average value of 14.90 mg/5mL (99.3%). Therefore, it is concluded that the finished product Dextromethorphan hydrobromide 15 mg/ 5 mL syrup complies with the technical specifications established by USP 42.
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Keywords
Dextrometorfano bromhidrato, Calidad fisicoquímica.