The expiry date printed on your medicines isn’t arbitrary—it’s carefully determined through rigorous stability studies to ensure the drug remains safe and effective throughout its shelf life.
Here’s a breakdown of how it’s done:
—Step 1: Stability Studies
Pharmaceutical companies test drugs under controlled conditions to monitor:Potency: The active ingredient should remain within 90–110% of its labeled content.Degradation: Impurities must stay below specified limits.Physical Stability: The product should maintain its appearance, hardness, and dissolution profile.Microbial Limits: The drug must not develop harmful microbial contamination.These studies are performed using samples stored under specific temperature and humidity conditions for months or years.
