Estabilidad a largo plazo de Ciprofloxacino 3mg/mL solución oftálmica de un laboratorio de industria farmacéutica nacional
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Date
2022
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Universidad Nacional de Trujillo
Abstract
Este informe de práctica preprofesional describe los ensayos realizados con ciprofloxacino. 3mg/mL solución oftálmica, con el propósito de determinar la estabilidad a largo plazo y la calidad fisicoquímica de acuerdo a las especificaciones estandarizadas por la Farmacopea de Estados Unidos de América (USP) 42, empleando una muestra de trabajo de 30 frascos de soluciones oftálmicas de un reconocido laboratorio farmacéutico nacional. Los resultados obtenidos fueron: Una solución transparente, incolora, un pH de 4,8; el ensayo de valoración está dentro del rango especificado con 3,13 mg/mL (104,2%) y el ensayo de conteo de partículas por obstrucción de luz se encontró 0 partículas de diámetro ≥ 10 um/ envase; cumpliendo todos los resultados de acuerdo a los valores establecidos en la norma oficial USP 42. Se concluye que ciprofloxacino 3mg/mL solución oftálmica cumple con las especificaciones de la técnica del laboratorio basados en la USP 42.
ABSTRACT This pre-pro field report describes tests performed with ciprofloxacin 3mg / mL ophthalmic solution, in order to determine the long-term stability and physicochemical quality according to the specifications established by the United States Pharmacopeia of America (USP). 42, using a study sample of 30 bottles of ophthalmic solutions from a national pharmaceutical laboratory. The results obtained were as description a clear, colorless solution. A pH of 4.8; the titration test is within the specified range with 3.13 mg / mL (104.2%) and the light obstruction particle count test found 0 particles of diameter ≥ 10 um / container; fulfilling all the results according to the values established in the official standard USP 42. It is concluded that ciprofloxacin 3mg / mL ophthalmic solution, complying with the specifications of the laboratory technique, based on USP 42.
ABSTRACT This pre-pro field report describes tests performed with ciprofloxacin 3mg / mL ophthalmic solution, in order to determine the long-term stability and physicochemical quality according to the specifications established by the United States Pharmacopeia of America (USP). 42, using a study sample of 30 bottles of ophthalmic solutions from a national pharmaceutical laboratory. The results obtained were as description a clear, colorless solution. A pH of 4.8; the titration test is within the specified range with 3.13 mg / mL (104.2%) and the light obstruction particle count test found 0 particles of diameter ≥ 10 um / container; fulfilling all the results according to the values established in the official standard USP 42. It is concluded that ciprofloxacin 3mg / mL ophthalmic solution, complying with the specifications of the laboratory technique, based on USP 42.
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Solución oftálmica