Impurities is defined as an entity of drug substances or drug product that is not chemical entity defined as drug substances an excipients or other additives to drug product. In pharmaceutical world, an impurity is generally considered as other organic material beside the drug substances that is arises out of the synthesis most of the time, inorganic contaminants are not considered as an impurity unless they are toxic, such as heavy metal or arsenic. There are numerous sources of impurities and many different common terms are used for impurities such as by product, intermediate, transformation on product, related product, interaction product and degradation products.

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High performance liquid chromatography (HPLC) is a powerful analytical technique used to separate, identify and quantify compounds with a wide range of differing properties.

The need to ensure that standards, organic solvents and HPLC mobile phases are of the highest purity is widely recognised, yet water quality, which may have a major impact on chromatographic performance, is frequently taken for granted. For ultra-high performance liquid chromatography (UHPLC), a technique using sub-2 µm particles and high pressures to enhance analytical speed and sensitivity, water quality is very crucial.

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