How to Support Store Below 25°C vs 30°C Claims

Recognizing signs that indicate potential temperature stability issues is the first step in addressing label claim justifications. The following symptoms may signal concerns that need immediate action:Click to read the…

How to Use Ongoing Stability Data to Extend Shelf-Life Claims

Utilizing Stability Data for Extended Shelf-Life Claims in Pharmaceuticals In today’s competitive pharmaceutical landscape, demonstrating the reliability of shelf-life claims through rigorous stability data is paramount. Poorly justified shelf-life can…

How to Support Retest Period Claims for APIs

It is essential to recognize potential signals that could indicate issues with label claim justification. Some symptoms may arise from stability studies or during routine testing of APIs. Common signals…