Epäpuhtaiden

Epäpuhtaiden is the genitive plural form of epäpuhtaus, a Finnish term meaning impurity or contaminant. In Finnish scientific and regulatory language, epäpuhtaudet describe substances that are undesired in a material because they affect quality, safety, or performance. The term is used across fields such as chemistry, pharmacology, food safety, environmental science and industry.

Impurities can be categorized by origin and type. Inorganic impurities include metals and mineral remnants; organic impurities cover residual solvents, byproducts, and degradation products; biological impurities concern microorganisms or toxins in certain contexts. Process-related impurities arise from catalysts, reagents, or equipment, while inherent impurities are those naturally present in raw materials. The relevance of impurities depends on the material and its intended use, with stricter limits in pharmaceuticals and certain foods.

Measurement and regulation rely on analytical methods such as high-performance liquid chromatography (HPLC), gas chromatography (GC), inductively coupled plasma mass spectrometry (ICP-MS), and spectroscopy. Impurity profiling involves identifying and quantifying individual impurities and assessing their risks. Regulatory frameworks typically specify acceptable impurity levels, identification requirements, and testing frequencies. In pharmaceuticals, guidelines (for example, ICH Q3A and Q3B) outline impurity identification and limits; in food and environmental contexts, national and EU regulations establish permissible contaminant thresholds.

Control and reduction of epäpuhtauksia employ purification and processing strategies: distillation, crystallization, extraction, filtration, precipitation, and chromatography, complemented by good manufacturing practices, quality control, and supplier qualification. Effective impurity management aims to ensure product safety, quality, and regulatory compliance while balancing production efficiency and cost.