In cases where the API itself is the extract from an herbal or animal tissue preparation, all constituents of this extract (concomitant constituents) might be considered to be part of the API. Therefore, a production process-related impurity profile (except, for example, solvents used in the process), would generally not be expected. However, for all APIs derived from herbal or animal sources, tests and limits for possible contaminants originating from these sources (e.g., pesticides, mycotoxins, viruses, herbicides, elemental impurities and wrong species) should be established, based on a risk assessment. In cases where herbal or animal sources provide material that is further processed to yield a chemically defined API, all constituents other than the API are considered impurities. In this situation, the API manufacturer would be expected to establish an impurity profile as well as an API release specification that would include impurity limits.In any case, it is the API manufacturer’s responsibility to establish batch release specifications for APIs to ensure that they are safe and of high quality, consistent with appropriate regulatory requirements, applicable compendial specifications and regional expectations [ICH Q7, Section 11.21; ICH Q9; ICH Q11].
