A "Major Impurity" refers to a significant contaminant or unwanted substance found in a material, often affecting its quality or performance. In various industries, such as pharmaceuticals and manufacturing, the presence of major impurities can lead to product failures, safety issues, or regulatory non-compliance. Identifying and controlling major impurities is crucial for ensuring the purity and effectiveness of products. Techniques like chromatography and mass spectrometry are commonly used to detect and quantify these impurities, helping companies maintain high standards and meet the requirements set by regulatory bodies like the FDA.