ABSTRACT
As indicated earlier, for every drug product on the market, the FDA requires that an expiration dating period (or shelf-life) be indicated on the immediate container label. The expiration date provides the consumer with the confidence that the drug product will retain its identity, strength, quality, and purity throughout the expiration period of the drug product. If the drug fails to remain within the approved specifications for the identity, strength, quality, and purity, the drug product is considered unsafe and subject to recall. To provide such assurance, pharmaceutical companies usually conduct stability studies to collect, analyze, and interpret data on the stability of their drug products throughout the expiration period. According to the FDA stability guidelines, the time at which the average drug characteristic (e.g., potency) remains within an approved specification after manufacture is recommended as the shelf-life of the drug product (FDA, 1987, 1998).
