Efficacies of Antimicrobial Conservants of Various Nonsterile Medicines for Oral Use

The efficacies of the antimicrobial conservants in a number of nonsterile medicinal formulations for oral use as syrups and solutions were evaluated, i.e., Klarisens® syrup 1 mg/ml, El’kar® solution for oral use, 300 mg/ml, Lasolvan® syrup 15 mg/5 ml, and others. The quality of seven study samples containing conservants such as benzoic acid, methylparaben, propylparaben, sodium benzoate, and ethanol complied with the requirements of General Pharmacopeia Monograph OFS 42-0069-07 “Determination of the efficacy of antimicrobial conservants in medicines”. The results of the studies reported here were obtained using a modified deep plate inoculation method recommended by the State Pharmacopeia of the Russian Federation XII edition for determination of the microbiological purity of medicines. The modified deep plate method has potential for use as a supplementary method, and inclusion in the next edition of the State Pharmacopeia of the Russian Federation is recommended.