1,2-Dichloroethane is a Class 1 residual solvent with known carcinogenic properties. As a USP reference standard, its presence in biologic products is strictly regulated to ensure that residual amounts remain within safe limits. Its detection is crucial for ensuring the safety of biologic products, as it can adversely affect patient health if present in excessive quantities.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.