Drug Stability Testing

"Drug Stability Testing: A Comprehensive Guide" is an essential resource for pharmaceutical professionals. This comprehensive guide covers critical aspects of pharmaceutical development and quality assurance, ensuring drugs maintain their potency, purity, and safety throughout their shelf life. The book adresses vital topics, including accelerated stability testing and real-time stability studies, which are crucial for predicting product longevity and validating results under real-world conditions.

Readers will explore the significant impact of environmental factors such as temperature, humidity, and light on drug stability. The guide also details various analytical techniques for stability assessment, including chromatographic and spectroscopic methods, and discusses problem-solving protocols with real-world case studies. Additionally, it provides insights into regulatory guidelines (ICH and FDA) and the application of Quality by Design (QbD) principles to optimize formulations. This book is an indispensable tool for mastering the complexities of drug stability and ensuring product quality.