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Impurity Profile
A description of the identified and unidentified impurities present in a typical batch of API (Active Pharmaceutical Ingredient) produced by a specific controlled production process. It includes the identity or some qualitative analytical designation (e.g. retention time), the range of each impurity observed, and type of each identified impurity. For each API there should be an impurity profile describing the identified and unidentified impurities present in a typical batch. The impurity profile is normally dependent upon the process or origin of the API.