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.
M-Scan offers analytical expertise in the detailed identification and quantification of residual solvents in medicinal products to ICH Topic Q3C. By using a proven Thermal Desorption GC-MS method M-Scan’s in-house method offers improved specificity over GC alone and improved sensitivity over Headspace GC-MS.
Studies can be carried out to GLP/GMP if required.
M-Scan Brochure: Biotechnology and Pharmaceutical Analysis (8pp.)