Stability of Pharmaceutical Products (original) (raw)

2020, Drug Stability and Chemical Kinetics

This chapter explains the concept of stability of pharmaceutical products as the extent to which they retain those properties and characteristics within the specified limits, throughout their period of storage and use, possessed at the time of their packaging. The terms like shelf-life and expiry are well defined here. The importance of stability of drug products describes the consequences of instabilities occurring in drug products. Types of stability mainly physical, chemical, microbiological, therapeutic, and toxicological stability have also been discussed concisely. Factors such as moisture, excipients, temperature, pH, oxygen, and light affect the efficacy, quality, and properties of drugs, which makes the drug either a toxic compound or a substance that has no or very little therapeutic activity. Instabilities among different pharmaceutical drug products and substances are explained along with the stability studies to evaluate their degradation behavior upon exposure to various parameters. Such parameters can be controlled according to the stability study type. The testing methods described in this chapter are real-time stability testing, accelerated stability testing, retained sample testing, and cyclic temperature stress testing along with their advantages and disadvantages. The standards for environmental conditions to be provided during such studies are set according to WHO and ICH guidelines. These studies play an important role during drug development stages and are considered as fundamental processes to be carried out for the approval and