Estabilidad a largo plazo de Dextrosa al 5%, envasado en empaque de Polietileno de baja densidad (PEBD) y Polipropileno (PP)
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre-profesionales tuvo como finalidad evaluar la estabilidad a largo plazo de Dextrosa 5% solución inyectable, envasada en empaque de Polietileno de baja densidad (PEBD) y Polipropileno (PP) de un laboratorio de industria farmacéutica nacional. La muestra estuvo conformada por 2 lotes de PEBD y 2 lotes de PP, se realizó un muestreo aleatorio simple. Se procedió con el ensayo de descripción por inspección visual sobre un fondo blanco, así mismo se determinó el pH, volumen, límite de 5-hidroximetilfurfural y sustancias relacionadas y dosaje del principio activo. Al comparar los resultados obtenidos entre los lotes de PEBD y PP se observó que no presentan diferencia significativa entre ellos. Esto se debió a que las industrias nacionales en el Perú cuentan con equipos modernos, que utilizan materia prima de alta calidad y la manufactura es de acuerdo a normas establecidas en las BPM. Evaluando los resultados obtenidos se encontró que las características fisicoquímicas de ambos materiales de empaque PEBD y PP, cumplen con las especificaciones establecidas por la Farmacopea Americana vigente, para una estabilidad de 12 meses de evaluación realizada en el presente informe.
ABSTRACT The purpose of this report on pre-professional practices was to evaluate the long-term stability of Dextrose 5% injectable solution, packed in Low Density Polyethylene (LDPE) and Polypropylene (PP) packaging from a national pharmaceutical industry laboratory. The sample consisted of 2 lots of LDPE and 2 lots of PP, a simple random sampling was carried out. The description test was carried out by visual inspection on a white background, likewise the pH, volume, limit of 5-hydroxymethylfurfural and related substances and dosage of the active principle were determined. When comparing the results obtained between the LDPE and PP batches, it was observed that they did not present a significant difference between them. This was due to the fact that the national industries in Peru have modern equipment, which use high quality raw materials and the manufacturing is in accordance with the standards established in the GMP. Evaluating the results obtained, it was found that the physicochemical characteristics of both PEBD and PP packaging materials comply with the specifications established by the current American Pharmacopoeia, for a stability of 12 months of evaluation carried out in this report.
ABSTRACT The purpose of this report on pre-professional practices was to evaluate the long-term stability of Dextrose 5% injectable solution, packed in Low Density Polyethylene (LDPE) and Polypropylene (PP) packaging from a national pharmaceutical industry laboratory. The sample consisted of 2 lots of LDPE and 2 lots of PP, a simple random sampling was carried out. The description test was carried out by visual inspection on a white background, likewise the pH, volume, limit of 5-hydroxymethylfurfural and related substances and dosage of the active principle were determined. When comparing the results obtained between the LDPE and PP batches, it was observed that they did not present a significant difference between them. This was due to the fact that the national industries in Peru have modern equipment, which use high quality raw materials and the manufacturing is in accordance with the standards established in the GMP. Evaluating the results obtained, it was found that the physicochemical characteristics of both PEBD and PP packaging materials comply with the specifications established by the current American Pharmacopoeia, for a stability of 12 months of evaluation carried out in this report.
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Keywords
Dextrosa 5%. Dosaje. Estabilidad a largo plazo