jäännösliuottimille

Jäännösliuottimet, or residual solvents, are organic volatile chemicals that remain in a finished pharmaceutical product, drug substance, or excipient. These solvents are used during the manufacturing process for various purposes, such as extraction, purification, or synthesis. While most of these solvents are removed during the manufacturing stages, trace amounts can persist in the final product.

The presence of residual solvents in pharmaceuticals is a concern due to their potential toxicity. Regulatory agencies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), have established guidelines (ICH Q3C) to limit the acceptable levels of residual solvents in drug products. These guidelines classify solvents based on their toxicity into three classes: Class 1 solvents are known or strongly suspected human carcinogens and should not be present; Class 2 solvents have inherent toxicity and their use should be minimized; and Class 3 solvents have low toxic potential and are generally permitted in amounts up to 50 mg/day.

Analytical methods like gas chromatography (GC) are commonly used to detect and quantify residual solvents in pharmaceutical products. Strict control and monitoring of residual solvent levels are essential to ensure the safety and quality of medicinal products. Manufacturers must implement robust manufacturing processes and analytical testing to comply with regulatory requirements and protect patient health.