The purpose of stability testing is to provide evidence on how the quality of an active pharmaceutical ingredient or medicinal product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the active pharmaceutical ingredient or a shelf life for the medicinal product and recommended storage conditions. The design of the stability-testing programme should take into account the intended market and the climatic conditions in the area in which the medicinal products will be used. The stability testing recommendations in this guideline cover the long-term storage condition for all Climatic Zones, i.e. I – IV. The shelf life should be established with due regard to the climatic zone(s) in which the products are to be marketed. For certain preparations, the shelf-life can be guaranteed only if specific storage instructions are complied with.
Contents of book include:
Chapter 1: Regulatory requirements for stability studies
Chapter 2: Factors affecting stability of pharmaceutical and cosmetic products
Chapter 3: Development of stability indicating methods
Chapter 4: Stability studies guidelines for pharmaceutical products
Chapter 5: IPEC excipients stability guidelines
Chapter 6: Stability testing of biological, biotechnological products
Chapter 7: Stability of cosmetic products