Collaboration within the basic test programme 1. In other words, the true product shelf life is defined to be the characteristic of the distribution of true batch shelf lives giving operational meaning to Q1A. The oxidation of some tablets, e. The Working Group's proposed definition of shelf life is illustrated in Fig. The product distribution is defined by both the between-batch and within-batch variation. Only a provisional shelf-life may be established on the basis of these studies. Exchange of evaluation reports.
A well known oxidation is the conversion of wine into vinegar; the ethanol is oxidised to acetic acid.
Why do medicines have expiry dates?
How are expiration dates established? This is because of the chemistry of many of the functional groups in drug molecules and the ubiquitous presence of water and oxygen. A patient may think it is an individual dosage unit. The appropriate conditions will depend on the drug, but may include considerations regarding temperature, humidity, and exposure to light. What potential risks are associated with expired drugs? Once opened, the shelf-life of some products, e. Q1A R2: