DEVELOPMENT AND VALIDATION OF MICROBIAL LIMIT TEST FOR FOSCARNET SODIUM API.

Gundepalli Ramanjaneyulu* and Yogesh Waghmare

ABSTRACT

The Foscarnet Sodium is an important drug used to treat viral infections. Majorly it acts on (CMV) Cytomegalovirus and Herpes Simplex Virus I and II. Foscarnet Sodium has antimicrobial properties. It must undergo neutralization of antimicrobial compounds to allow microbial count testing according to recommendations by the official pharmacopoeias. The validation of antimicrobial activity neutralization and of the method for the microbial counting was performed according to USP 40. Lecithin soya used as neutralizer, Recovery levels over 70% of the microorganisms used in the test indicated the neutralization of antimicrobial activity and proved the absence of toxicity of neutralizer. The microbial counting method validated and proved accurately.

Keywords: Microbial limit test, Foscarnet sodium, validation and development, soya lecithin.