Aptitud del método microbiológico de análisis de un producto farmacéutico líquido, elaborado en el laboratorio de farmacología vegetal (LABFARVE).

Abstract

The verification of the method using the different working conditions is necessary and required in Colombia by decree 1156 of 2018 of the Ministry of Social Protection to verify that the methodology to be used in the analyzes is correct. To evaluate the aptitude of the method, counts of aerobic mesophiles, molds, yeasts were carried out, and tests of specific microorganisms were carried out, in the presence and absence of the product according to the provisions of the United States Pharmacopeia Convention (USP) chapter <61> and <62>. They were made with certified strains which were: Bacillus subtilis ATCC® 6633TM, Escherichia coli ATCC® 8739TM, Staphylococcus aureus ATCC® 6538TM, Pseuodomonas aeruginosa ATCC® 9027TM, Salmonella Typhimurium ATCC® 14028TM, Candida albicans NCPF 3179 and Aspergillus brasiliensis ATCC® 16404TM; In order to demonstrate the aptitude of the method in each batch, the recovery percentage obtained must be between 50% - 200% and obtain the presence of the specific inoculated microorganisms, verifying that both the macroscopic and microscopic characteristics of the microorganism correspond to the strain used. The results obtained were in accordance with the established acceptance criteria. According to the study carried out, it was possible to demonstrate through the enumeration and recovery tests of the specific microorganisms, that the method for the microbiological analysis of non-sterile products of the current USP is appropriate to be used in the microbiological analysis of the Valeriana oral solution product. x 60 ml, produced and marketed at LABFARVE.