June 23rd 2025
Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.
Total Analytical Error in Validation of Analytical Procedures of Pharmaceuticals
May 2nd 2023This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors.
Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>
Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.