Define Worst-Case Batch Criteria Before Starting Stability Studies
Understanding the Tip: What is a ‘worst-case batch’ and why does it matter? In stability testing, not all batches are created equal. A ‘worst-case batch’ is one that presents the highest risk for instability based on factors such as manufacturing scale, impurity load, container-closure system, or storage conditions. Testing such a batch helps simulate the…
Read More “Define Worst-Case Batch Criteria Before Starting Stability Studies” »