Residual solvents in pharmaceuticals are classified from Class 1 to 3 based on their potential human health risk. Since these compounds are strictly controlled, highly sensitive analysis is required. Helium (He) is generally used as the carrier gas, but as He supply shortages have become an issue recently, analysis using an alternative carrier gas such as N2 has also been in demand lately.
Satisfactory results were obtained with Procedure A, meeting the requirements of JP17 Supplement II which states that “the S/N ratio for 1,1,1-trichloroethane in the Class 1 standard solution is not less than 5 and the relative standard deviation of each peak area is not more than 15 %.” Results obtained with Procedure B were also satisfactory as “the S/N ratio for benzene in the Class 1 standard solution is not less than 5 and the relative standard deviation of each peak area is not more than 15 %.”