Used for detecting residual E. coli DNA in biopharmaceutical products to ensure product safety and compliance with regulatory standards. The kit helps monitor and validate the effectiveness of purification processes during the manufacturing of recombinant proteins and other therapeutics produced in E. coli expression systems. It is particularly employed in quality control laboratories to meet requirements set by pharmacopeias such as USP <1135> and other global regulatory guidelines. The detection method supports risk assessment for host cell DNA contamination, which is critical for final product release and patient safety.