Controles fisicoquímicos de sulfato de magnesio 20% inyectable en ampolla de vidrio y polietileno de baja densidad en un laboratorio farmacéutico nacional
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El objetivo del informe de prácticas fue comparar los valores de los controles fisicoquímicos de sulfato de magnesio 20% inyectable en ampolla de vidrio y polietileno de baja densidad (PEBD) en la etapa de envase, en un laboratorio nacional, analizando 10 lotes (5 lotes de ampollas de vidrio y 5 lotes de ampollas PEBD) manufacturados durante los meses de junio a agosto del 2020. Para lo cual, se realizaron controles de peso específico, pH, control de volumen, inspección visual y hermeticidad. Se encontraron valores similares para ampollas de vidrio y de PEBD como peso específico 1,0908 y 1,0928; pH 6,58 y 6,76; control de volumen 10,35 mL y 10,79 mL, respectivamente. Además, la inspección visual fue conforme para ambos tipos de envase y hermeticidad para el envase de PEBD. Se concluye que los valores de los controles fisicoquímicos de los lotes analizados de sulfato de magnesio al 20% inyectable en ampollas de vidrio y PEBD durante la etapa de envase presentan las mismas especificaciones en peso específico, pH, volumen e inspección visual.
ABSTRACT The objective of the practice report was to compare the values of the physicochemical controls of magnesium sulfate 20% injectable in glass ampoule and low- density polyethylene (LDPE) in the packaging stage, in a national laboratory, analyzing 10 batches (5 batches of glass ampoules and 5 lots of LDPE ampoules) manufactured during the months of June to August 2020. For which, specific weight, pH, volume control, visual inspection and airtightness controls were carried out. Similar values were found for glass ampoules and LDPE as specific gravity 1.0908 and 1.0928; pH 6.58 and 6.76; volume control 10.35 mL and 10.79 mL, respectively. In addition, the visual inspection was compliant for both types of container and hermeticity for the LDPE container. It is concluded that the values of the physicochemical controls of the analyzed batches of magnesium sulfate 20% injectable in glass ampoules and LDPE during the packaging stage present the same specifications in specific weight, pH, volume, and visual inspection
ABSTRACT The objective of the practice report was to compare the values of the physicochemical controls of magnesium sulfate 20% injectable in glass ampoule and low- density polyethylene (LDPE) in the packaging stage, in a national laboratory, analyzing 10 batches (5 batches of glass ampoules and 5 lots of LDPE ampoules) manufactured during the months of June to August 2020. For which, specific weight, pH, volume control, visual inspection and airtightness controls were carried out. Similar values were found for glass ampoules and LDPE as specific gravity 1.0908 and 1.0928; pH 6.58 and 6.76; volume control 10.35 mL and 10.79 mL, respectively. In addition, the visual inspection was compliant for both types of container and hermeticity for the LDPE container. It is concluded that the values of the physicochemical controls of the analyzed batches of magnesium sulfate 20% injectable in glass ampoules and LDPE during the packaging stage present the same specifications in specific weight, pH, volume, and visual inspection
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Keywords
Sulfato de magnesio. Control fisicoquimico. PEBD. Vidrio