Article | July 2, 2020

Impurity Identification In Small-Molecule APIs

Source: Albemarle
small molecule, nce

Impurities of principal concern are often first discovered through final product purity analysis, which for most small molecule drug substances utilizes high-performance liquid chromatography (HPLC) with UV detection. However, tracking and identification of impurities observed in in-process control testing, along with purity analysis of raw materials, can also be important to managing the total impurity profile of a drug — it is this control strategy that is most important to successful manufacturing and commercialization.

Timely identification of impurities requires a unique combination of process chemistry knowledge and considerable analytical capabilities.

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