Tag: shelf life calculation

API Degradation Pathways and Their Effect on Expiry Dating

Drug products are only as stable as their active pharmaceutical ingredients (APIs). Understanding the degradation behavior of APIs is crucial for setting scientifically justified expiry dates. In this tutorial, we explore common degradation pathways, how they impact expiry dating, and what pharma professionals should consider when planning stability studies and regulatory filings. 🔬 Why Degradation…

Factors Affecting Drug Shelf Life (Storage Conditions, Container, Light, etc.), Shelf Life and Expiry

ICH Q1E and Stability Data Evaluation in Pharmaceutical Submissions

ICH Q1E and Stability Data Evaluation in Pharmaceutical Submissions ICH Q1E and Stability Data Evaluation in Pharmaceutical Submissions Introduction Stability data forms the foundation for assigning pharmaceutical shelf life and defining product storage conditions. However, collecting data is only half the task—the analysis and interpretation of this data must be scientifically rigorous and statistically sound….

ICH Q1E and Stability Data Evaluation, Protocols and Reports