In the manufacturing industry, solvents play a critical role throughout the manufacturing process. Solvents can be used to clean assembly line equipment to the development of pharmaceutical products. The residual solvents are those that are not completely removed after processing. Residual solvents are organic volatile chemicals that are used or produced in the manufacturing process of drug substances or excipients, or in the preparation of drug products.
Residual Solvent testing with ChRi Labs helps you ensure product quality and safety. During pharmaceutical production, ethanol and other solvents are often used. Since the majority of pharmaceutical products are ingested into the body, residual solvent testing ensures that these solvents are not present at threatening levels. The ICH guideline Q3C (R5) and USP <467> provide analytical methods and permissible daily exposure for some of the commonly used solvents.
At ChRi, we use Headspace GC/MS for residual solvent testing to help identify the precise composition of a sample. A static headspace analysis for analyzing residual compounds can detect both volatile and semi-volatile organic compounds given off by a sample during heating or over time. As a cGMP lab, we have some of the most stringent quality standards to which we conduct analysis. Our techniques are accurate enough to identify and quantify which residual solvents are present in a sample. This allows manufacturers to be able to trace the issues to a specific step in the manufacturing process.