Highly Sensitive UV Analysis with the Agilent 1290 Infinity LC System for Fast and Reliable Cleaning Validation – Part 3 Determination of residual active pharmaceutical impurities from a previous production batch using a DAD with standard or high sensitivity flow cell
This document is Part 3 of a series describing a quality control workflow for cleaning validation in the pharmaceutical industry. It focuses on detecting contamination of an active pharmaceutical product (APP) with remains from a previous production batch. The study compares the detection capabilities of a standard 10 mm flow cell versus a high sensitivity 60 mm flow cell within the Agilent 1290 Infinity LC system equipped with a DAD.
This document studies the detection of contamination of an active pharmaceutical product with the remains of another APP.
The amount of contaminant must not be higher than 1/1000 of the normal dose of an APP present per typical dose of the subsequent product.
The high sensitivity detection achieves about five times higher sensitivity than the standard cell.