(1994; 52 pages)
Definitions used in the study
Table I: Definitions used in the study
Stability: The ability of a drug to retain its properties within specified limits throughout its shelf-life. The following aspects of stability are to be considered: chemical, physical, microbiological and biopharmaceutical.
Shelf-life: The period of time during which a drug product is expected, if stored correctly, to remain within specifications as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch.
Source: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva: 1990; Tech Rep Series 790:30