Shelf life

The period of time between the manufacture and the expiry date of a speciality (finished medicinal product) or extemporaneous preparation. During this time, consistent quality is guaranteed if the medicine is stored correctly. The shelf life of extemporaneous preparations is determined by the chemical stability of the active ingredients and excipients, the physical stability of the preparation and the microbial stability of the end product. The water content of the formulation base plays an important role here, as water-containing formulation bases lead to instability more often than anhydrous ones.