By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services
Improper detection and removal of residual solvents in raw materials and drug products can cause significant risks to quality and safety.
In many cases, solvents used to maximize production yields are difficult to eliminate. Too often, residual amounts of acetonitrile; chlorobenzene; 1,2-dimethoxyethane; and other powerful yet potentially harmful solvents remain in drug substances, excipients, and products.
U.S. Pharmacopeia (USP) Chapter <467> divides residual solvents into three classes based on toxicity. Class 1 solvents are to be avoided. They are either known or suspected human carcinogens. Class 2 solvents are effective yet potentially toxic. Class 3 solvents have low toxicity but are less effective as purification agents.
Traditional manufacturing techniques do not adequately remove most residual solvents.
Read how Nitto Avecia Pharma Services detailed knowledge of residual solvent study designs can meet agency expectations and understands which protocols work best for specific samples.