ABSTRACT
Stability can be defined as the ability of the active pharmaceutical ingredients (APIs) or pharmaceutical dosage forms to maintain their therapeutic, microbial, chemical and physical properties at the time of its consumption. The stability testing of parenteral formulation is a complex set of processes which involves time, cost and expertise in the required field to build the safety, quality and efficacy of the developed formulation. A variety of factors like stability, physicochemical interaction between excipients and APIs, dosage forms, manufacturing processes, containers, and effect of heat, light, and moisture content are considered. Apart from that degradation reaction like hydrolysis, oxidation–reduction also plays a vital role in the stability of pharmaceutical preparations. For better acceptance of the result, it is always recommended to follow official compendia because any alternate method apart from the official ones required validation before acceptance.
