Validation and performance qualification of a new formulation system for parenteral solutions: The case of dextrose and metronidazole

Abstract

A performance evaluation was conducted on the parenteral solutions Dextrose 5% x 500 mL and Metronidazole 0.5% x 100 mL at the "Eastern Pharmaceutical Laboratory" to demonstrate that the new system meets the predefined specifications and requirements for its intended purpose. The study began with process characterization. Samples were collected throughout 2025, and the physical, chemical, and microbiological parameters of both parenteral solutions were determined. In the case of the Metronidazole 0.5% x 100 mL parenteral solution, the results were satisfactory. The pH was within the acceptable range; the chloride and metronidazole concentrations were within limits, as shown in the graphs. The organoleptic characteristics were characterized by a bitter taste and the absence of particles. Sterility was demonstrated by the absence of viable microorganisms, and bacterial endotoxins were < 1.75 EU/mL. For the Dextrose 5% x 500 mL parenteral solution, the analyzed data were excellent: pH and concentration within established limits; organoleptic aspects revealed a sweet-tasting solution free of particles; sterility was confirmed with the absence of viable microorganisms; and bacterial endotoxins were < 0.5 EU/mL. These results confirm the system's functionality, demonstrating its reliability and supporting its validation.