The ICH Guideline for residual solvents completed step 5, final adoption by Committee for Human Medicinal Products (CHMP) on 15th December 2016.
This guideline recommends acceptable amounts for residual solvents in medicines with regard to patient safety. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
Levels of residual solvents in drug products must be supported by safety data. Some solvents that are known to cause unacceptable toxicities (Class 1) should be avoided in the production of drug substances, excipients and drug products unless their use can be full supported with a balanced risk-benefit assessment. Solvents associated with less severe toxicity (Class 2) can be used but should be limited in order to protect patients from potential adverse effects. It is preferable that less toxic solvents (Class 3) are used whenever practical.
The guideline formally comes into effect on 14th June 2017.
Click here to access the guideline.