Analysis of Residual Solvents in Pharmaceutical Products
The ICH Harmonised Tripartite Guidelines set up by the EU, Japan and USA for the registration of medicinal products require under ICH Topic Q3C ‘testing to be performed for residual solvents when production or purification processes are known to result in the presence of such solvents’. These guidelines set criteria for analytical methods used to identify and quantify these residual solvents as well as providing acceptable concentration limits.
SGS M-Scan offers analytical expertise in the detailed identification and quantification of residual solvents to ICH Topic Q3C in pharmaceutical products using a proven Thermal Desorption GC-MS method and Headspace GC-MS, which offer improved specificity over GC alone.
Our laboratories are GLP/cGMP compliant, FDA inspected and DEA licensed.