What are residual solvents?
Residual solvents in pharmaceutical products are organic volatile compounds that are used or created when drug substances, excipients, or additives are manufactured, prepared, or packaged and stored. Residual solvents are sometimes crucial in the synthesis of drug substances. Often, residual solvents are necessary to ameliorate the quality of drug substances or excipients. However, because they have no therapeutic value, if residual solvents are not completely removed by practical manufacturing methodologies, they must be evaluated and justified.
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. However, residual solvents may be harmful to human health and to the environment if their presence exceeds tolerance limits as determined by safety data. As a result, residual solvents testing has become an important quality control player in pharmaceuticals.
In recent years, testing for residual solvents has grown in demand as the demand by the FDA for such testing has increased. New Jersey Laboratories owns the latest technology in this space, called Headspace GC (HSGC). HSGC is ideal because of its ability to quantify individual solvents. Although most laboratories do basic testing on residual solvents, New Jersey Laboratories also performs more difficult tests on solvents such as poloxamers.
We are highly proficient in this area, and can walk you through every step.
When would you commonly test for residual solvents?
Testing for residual solvents is most common in the pharmaceutical field, where manufacturers are required by regulation to ensure that pharmaceuticals are free from toxicologically significant levels of volatile organic compounds.
What methods do you follow for residual solvents?
We perform the following methods for residual solvents:
||Ethylene Oxide and Dioxane
||Organic Volatile Impurities
||Ethylene Glycol, Diethylene Glycol and Triethylene Glycol in Ethoxy1ated Substances