Tag: Analytical Consistency

Ensure Availability of Reference Standards Across the Full Study Period

Understanding the Tip: Why uninterrupted access to reference standards is critical: Stability studies often span multiple years, and consistency in analytical testing is essential. Reference standards—whether primary (e.g., compendial) or secondary (working standards)—form the foundation of accuracy and precision in assay, impurity, and identification testing. Using different lots of standards without bridging studies or requalification…

Stability Study Tips

Conduct Inter-Laboratory Comparisons to Ensure Stability Data Consistency

Understanding the Tip: What are inter-laboratory comparisons in pharmaceutical stability: Inter-laboratory comparisons (ILCs) involve testing the same sample batch across different laboratories—either internal sites or contract labs—to compare results for critical parameters like assay, impurities, dissolution, or moisture content. These studies help validate the consistency, accuracy, and reproducibility of analytical methods when used at multiple…

Stability Study Tips