Why test for residual solvents? It is important to test for residual solvents because manufacturing techniques may not completely remove these organic volatile chemicals. Solvents are used in the manufacturing process for a variety of reasons such as better yield or improving the purity or solubility of a drug. Solvents can be important elements in the manufacturing process, however, can also present a risk to the patient. Since they can be a risk to the patient and they have no therapeutic benefit, residual solvents need to be tested and controlled.
Safety data based on potential risk to human health has been established for residual solvents and different risk classes have been established by both the USP and ICH Q3C (R8). As listed in the USP and ICH Q3C the classes are:
Primera can work with you and your team to determine if your drug substance, excipients, or drug product have any residual solvents that result from manufacture, packaging or drug storage. We are experienced in running USP Chapter <467> procedures or we can develop and validate methods specifically for you by Head-Space Gas Chromatography (HS-GC) or Gas Chromatography – Mass Spectrometry (GC-MS).
Our team of experts will work with you to determine the best option for you. All work is conducted with adherence to cGMP practices and therefore will meet all regulatory requirements for your submission.
Maintaining state-of-the-art instrumentation to detect, identify and quantitate residual solvents is critical to our clients. Primera’s instruments for residual solvents analysis include:
Primera’s typical approach to USP <467> is: