Residues of solvents used in the production of APIs and excipients or in the manufacture of finished products must be evaluated according to relevant Pharmacopoeia for the safety of the patient.
Analysis for residual solvents in pharmaceutical raw materials or finished products is performed according to the pharmacopoeias Ph. Eur. 2.4.24 Identification and control of residual solvents and 5.4 Residual solvents or USP <467> or by CEP methods, typically performed by GC headspace. Other methods can be used if needed, e.g. GC-FID or GC-MS for precise identification of solvents.

Please contact Cecilie for further information on analysis of residual solvents by GC.