EN PL

EMA: Scientific guideline: ICH: Q 3 C (R4): Impurities: Residual solvents - Step 5, adopted

19.07.2010
The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.