Impurities in a pharmaceutical compound or a NCE originate mainly from the raw materials, solvents, intermediates, and byproducts of the synthesis process. The raw materials generally have much lower purity requirements than a drug substance.

What is the process of impurities?

Process impurities are related to the manufacturing process and may include cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or chromatographic media used in purification, solvents and buffer components.

What is nature of impurity?

An impurity is something that ruins the uncontaminated nature of something. If someone accuses you of impurity, they think you or your nature has been spoiled in some way by sin. When water is pure, the only thing in that water is water.