Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.
Butterworth Labs have been providing Residual Solvents Analysis for many years. In addition to the routine use of GC and GC-MS headspace analysis, we have developed our own procedures for solvents such as Ethylene Glycol, which are best undertaken by direct injection. A number of chemicals listed as Class 3 Solvents, such as Formic and Acetic acids are not readily amenable to analysis by headspace GC. For these we use an alternative technique, Ion Chromatography.
Our allowable enhancements to sample preparation schemes with the careful choice of analytical column provides a significant improvement in Accuracy, Precision and Efficiency in comparison to the current pharmacopeial procedures.
To find out more please read our technical paper
To request a quotation for Residual Solvents Analysis please use our contact form