Control de calidad fisicoquímico de clorfenamina 2.0mg/5.0mL jarabe de un laboratorio farmacéutico nacional, 2021
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas titulado: “Control de calidad fisicoquímico de clorfenamina 2.0mg/5.0mL jarabe de un laboratorio farmacéutico nacional, 2021”, fue desarrollado en el área de control de calidad de un laboratorio nacional. Su finalidad fue evaluar la calidad fisicoquímica de cuatro lotes de un mismo producto utilizando 16 frascos de jarabe de cada uno. Los ensayos se desarrollaron según la técnica analítica propia del laboratorio, estos fueron: descripción, volumen de entrega, medición de pH, rotación óptica, identificación del analito por UHPLC, valoración del principio activo en la formulación y peso específico. Los resultados obtenidos fueron: en el ensayo de descripción se observó soluciones de color rojo, sabor dulce y olor a fresa. Los volúmenes de entrega se encontraron en promedio 124.0 mL, 123.0 mL,122.0 mL y 123.0 mL. La medición del pH arrojó valores de 4.8, 4.9, 4.9 y 4.9. La rotación óptica de los lotes resulto +0.001, +0.002, +0.001 y +0.003. En la identificación del analito se observó que los tiempos de retención de la muestra son similares al tiempo de retención de la solución estándar. Al realizar el ensayo de valoración, se obtuvo concentraciones promedio de 2.0 mg/mL, 1.98 mg/mL,1.96 mg/mL y 1.96 mg/mL que cumplen con los parámetros de la USP. Finalmente, para el ensayo de peso específico se tuvieron valores de 1.1295, 1.1289, 11298 y 1.1294. Ante lo mencionado, se concluye que el producto terminado clorfenamina 2.0mg/5.0mL jarabe de un laboratorio farmacéutico nacional cumple con las especificaciones descritas por la técnica analítica propia del laboratorio.
ABSTRACT This practice report entitled: "Physicochemical quality control of chlorphenamine 2.0mg/5.0mL syrup of a national pharmaceutical laboratory, 2021", was developed in the quality control area of a national laboratory. Its purpose was to evaluate the physicochemical quality of four batches of the same product using 16 syrup bottles of each one. The tests were developed according to the laboratory's own analytical technique, these were: description, delivery volume, pH measurement, optical rotation, identification of the analyte by UHPLC, assessment of the active ingredient in the formulation and specific weight. The results obtained were: in the description test, solutions of red color, sweet taste and strawberry smell were observed. The delivery volumes were found to be on average 124.0 mL, 123.0 mL, 122.0 mL and 123.0 mL. The pH measurement showed values of 4.8, 4.9, 4.9 and 4.9. The optical rotation of the lots was +0.001, +0.002, +0.001 and +0.003. In the identification of the analyte, it was observed that the retention times of the sample are similar to the retention time of the standard solution. When performing the titration test, average concentrations of 2.0 mg/mL, 1.98 mg/mL, 1.96 mg/mL and 1.96 mg/mL were obtained, which comply with USP parameters. Finally, for the specific weight test, values of 1.1295, 1.1289, 11298 and 1.1294 were obtained. Given the above, it is concluded that the finished product chlorphenamine 2.0mg/5.0mL syrup from a national pharmaceutical laboratory meets the specifications described by the laboratory's own analytical technique.
ABSTRACT This practice report entitled: "Physicochemical quality control of chlorphenamine 2.0mg/5.0mL syrup of a national pharmaceutical laboratory, 2021", was developed in the quality control area of a national laboratory. Its purpose was to evaluate the physicochemical quality of four batches of the same product using 16 syrup bottles of each one. The tests were developed according to the laboratory's own analytical technique, these were: description, delivery volume, pH measurement, optical rotation, identification of the analyte by UHPLC, assessment of the active ingredient in the formulation and specific weight. The results obtained were: in the description test, solutions of red color, sweet taste and strawberry smell were observed. The delivery volumes were found to be on average 124.0 mL, 123.0 mL, 122.0 mL and 123.0 mL. The pH measurement showed values of 4.8, 4.9, 4.9 and 4.9. The optical rotation of the lots was +0.001, +0.002, +0.001 and +0.003. In the identification of the analyte, it was observed that the retention times of the sample are similar to the retention time of the standard solution. When performing the titration test, average concentrations of 2.0 mg/mL, 1.98 mg/mL, 1.96 mg/mL and 1.96 mg/mL were obtained, which comply with USP parameters. Finally, for the specific weight test, values of 1.1295, 1.1289, 11298 and 1.1294 were obtained. Given the above, it is concluded that the finished product chlorphenamine 2.0mg/5.0mL syrup from a national pharmaceutical laboratory meets the specifications described by the laboratory's own analytical technique.
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Keywords
Control de calidad, Técnica analítica, Clorfenamina.