INTRODUCTION

Antimicrobial preservatives are substances added to aqueous pharmaceutical products. Nonsterile dosage forms may have preservatives added to protect them from growth of microorganisms inadvertently introduced during or subsequent to the manufacturing process. In the case of sterile articles packaged in multiple-dose containers, antimicrobial preservatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual doses. One or more antimicrobial preservative(s) are expected in all sterile multidose units.