Calidad fisicoquímica de diclofenaco sódico 0,1% solución oftálmica de un laboratorio farmacéutico nacional

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  • This report on pre-professional practices describes the tests realized to 0.1% diclofenac sodium ophthalmic solution, with the purpose of determining the physicochemical quality based on a laboratory technique and guided according to the specifications established by the Pharmacopoeia of United Stat...

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Main Author: Nuñez Hernandez, Jordy Michael
Format: Tesis de grado
Language: spa
Published: 2019
Subjects:
Online Access: http://dspace.unitru.edu.pe/handle/UNITRU/14252
Summary:This report on pre-professional practices describes the tests realized to 0.1% diclofenac sodium ophthalmic solution, with the purpose of determining the physicochemical quality based on a laboratory technique and guided according to the specifications established by the Pharmacopoeia of United States of America (USP 41), using a study sample of 120 bottles of ophthalmic solutions from a national pharmaceutical laboratory. The results obtained were as a description a clear, colorless to yellow solution; an average volume of 5.2 mL and pH 7.81; in the identification by high performance liquid chromatography the retention time of the main peak in the chromatogram of the sample preparation corresponds to that of the chromatogram of the standard preparation, as obtained in the titration; In the particle count test for light obstruction, 11 particles of diameter ≥ 10 μm were found and the pharmaceutically active ingredient titrated was within the specified range with 0.993 mg / mL (99.3%); fulfilling all the results according to the acceptance criteria of the own technique of the guided laboratory of the USP 41. It is concluded that diclofenac sodium 0.1% ophthalmic solution meets the specifications

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