Impurities

What are Impurities?

Impurities are undesired components present in the drug substance or drug product. These Impurities may derive from the product or from the process. The impurities derived from product are called product related impurities and those derived from the process are known as process related impurities. These impurities often present at very low or trace levels in highly complex sample matrices. Consequently, to measure these impurities, highly sensitive and specific analytical methods are required.