Abstract

ACTIVE PHARMACEUTICAL INGREDIENTS IN STERILE MANUFACTURING: A REVIEW

Umesh Mane*, Sachin S. Mali, Sagar Pol, Vilasrao Kadam, Krutika Gharat, Arati Bokade and Pranali Ghosalkar

ABSTRACT

Active Pharmaceutical Ingredients (API’s), used as ingredients in sterile medicinal products, must be sterile unless the final dosage form is terminally sterilized, or produced by a process including a sterilising filtration step. API’s intended for use in parenteral products must also comply with relevant specifications on pyrogens or bacterial endotoxins. The manufacture of sterile API’s must be strictly controlled in order to minimise the risk of contamination with micro-organisms, endotoxins and particles. If the final dosage form is not to be sterilised by filtration, the API’s should be practically free of particles.

Keywords: Active Pharmaceutical Ingredients, Parenteral products etc.