The United States Pharmacopoeia (USP) defines an impurity profile as “a description of the impurities
present in a typical lot of drug substance produced by a given manufacturing process.” (ref. USP <1086>).
Each commercial lot should be comparable in purity to this standard release profile which is developed early
on and maintained for each pharmaceutical chemical. We can also call this profile a “Reference Profile” because the quality control unit refers to it (1) when assessing the purity of each batch of active pharmaceutical ingredient (API), and (2) when evaluating the viability of proposed process changes.
