Residual Solvent Class 2 - Chlorobenzene

Chlorobenzene is a Class 2 residual solvent, with moderate toxicity concerns. As a USP reference standard, its presence in biologic formulations must be monitored carefully to ensure compliance with safety limits. The inclusion of chlorobenzene in biologics is restricted, and its levels must be controlled to prevent harmful effects on patients.

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.