chapter  8
9 Pages

Stability Studies

The definition of stability has evolved over time with different meanings by different organizations. For example, the stability in the context of dispensing for pharmacists is defined differently (USP/NF, 1990) from that in the context of pharmaceutical dosage forms for manufacturer. Carstensen (1990) gave the following definition: "The term pharmaceutical stability could imply several

things. First of all, it is applied to chemical stability of a drug substance in a dosage form, and this is the most common interpretation. However, the performance of a drug when given as a tablet . . . depends also on its pharmaceuticas properties (dissolution, hardness, etc.). All of these aspects must, therefore, be a part of the stability program." In the 1987 FDA guideline for the stability of human drugs and biologics (FDA, 1987), stability is defined as "the capacity of a drug product to remain within specifications established to ensure its identity, strength, quality, and purity."