Include Label Claims for Opened Vials or Devices in Stability Studies
Understanding the Tip: Why in-use stability matters for opened products: Once a vial, syringe, pen, or container is opened, its exposure to air, moisture, light, or microbial contaminants increases. The original shelf life no longer applies, and a new “in-use” period must be scientifically determined to guide patients and healthcare professionals. Without data to support…
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