jäännösliuottimien

Jäännösliuottimet refers to residual solvents that may be present in pharmaceutical products. These are organic volatile chemicals used as solvents in the manufacturing process of active pharmaceutical ingredients (APIs) and excipients. While essential for synthesis, purification, and formulation, it is crucial to minimize their presence in the final drug product due to potential toxicity. Regulatory bodies like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have established guidelines, specifically ICH Q3C, to classify and limit the acceptable levels of these solvents in pharmaceuticals.

Solvents are typically categorized into three classes based on their toxicity. Class 1 solvents are considered highly toxic and should be avoided or used with extreme caution, with very strict limits. Class 2 solvents have inherent toxicity and require limits to protect patient safety. Class 3 solvents are of low toxic potential and generally have no strict limits, though they are still monitored. The presence and concentration of jäännösliuottimet are determined using analytical techniques such as gas chromatography (GC). Manufacturers must ensure that residual solvent levels in their products are below the specified limits to guarantee the safety and quality of the medication. Effective drying and purification steps during manufacturing are key to achieving these low levels.