How do you claim shelf life of APIs?

Answer 1

To claim the shelf life of Active Pharmaceutical Ingredients (APIs), stability studies must be conducted according to regulatory guidelines, such as those from the ICH. These studies involve storing the API under specified conditions and testing it at regular intervals to assess its potency, purity, and quality over time. The results are then used to establish the expiration date, which is included in the product labeling. Documentation of these studies and results is crucial for regulatory submissions and compliance.