Bibliographic citations
Torres, R., (2022). Control de Calidad fisicoquímico de Olopatadina 0,2% Solución Oftálmica de un laboratorio farmacéutico nacional [Universidad Nacional de Trujillo]. https://hdl.handle.net/20.500.14414/20152
Torres, R., Control de Calidad fisicoquímico de Olopatadina 0,2% Solución Oftálmica de un laboratorio farmacéutico nacional []. PE: Universidad Nacional de Trujillo; 2022. https://hdl.handle.net/20.500.14414/20152
@misc{renati/1043559,
title = "Control de Calidad fisicoquímico de Olopatadina 0,2% Solución Oftálmica de un laboratorio farmacéutico nacional",
author = "Torres Navarro, Rosita Constanza",
publisher = "Universidad Nacional de Trujillo",
year = "2022"
}
ABSTRACT This report on pre-professional practices describes the physicochemical tests carried out in Quality Control of the Pharmaceutical Product Olopatadine 0.2% Ophthalmic Solution, according to the specifications established in the Pharmacopoeia of the United States of America (USP-NF 2021). A study sample of 140 ocuvials in the pharmaceutical form of ophthalmic solution from a national pharmaceutical laboratory was used. The results obtained from the pharmaceutical product were. As for the test Description: Clear, colorless solution. Free of visible particles, with an average volume of 0.4 mL and pH 6.9; the identification of Olopatadine Hydrochloride the retention times of the main peak of the sample solution corresponds to that of the standard solution, with RTST = 6.24 minutes and RTMP = 6.26 minutes, in addition to the UV spectrum of the main peak in the range of 270 – 370 nm of the sample solution corresponds to that of the standard solution; the titration test is within the specified range with 2.00 mg/mL (100,0 %) and the light obstruction particle count test found 0 particles with diameter ≥ 10 μm, 0 with ≥ 25 μm and 0 ≥ 50 μm; are in accordance with the specifications established in the standard of the official Pharmacopoeia USP-NF 2021. Regarding the analysis of impurities, both for early and late elution impurity limits, they comply with the specification according to the Pharmacopoeia of the United States of America (USP-NF 2021). Therefore, it is concluded that the pharmaceutical product Olopatadine 0.2% Ophthalmic Solution is in accordance with the specifications of the USP-NF 2021.
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