What are requirements of maintaining an impurity profile?
A.2 The 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. For further information regarding the control of impurities, refer to the following documents available on the International Conference on Harmonization Website (http://www.ich.org): Impurities in New Drug Substances – ICH Topic Q3A); Impurities in New Drug Products – ICH Topic Q3B). (September 9, 2003) Q.3 Does every individual container of an active pharmaceutical ingredient (API) need to be sampled
