According to ICH Q7, which of the following best describes the requirements for impurity profiles of APIs?

Choices

1. A. Impurity profiles are only needed for APIs used in clinical trials
2. B. The impurity profile should be compared at appropriate intervals against the impurity profile in the regulatory submission, and it should describe identified and unidentified impurities
3. C. Only genotoxic impurities require profiling; other impurities need only meet overall purity limits
4. D. Impurity profiles need only be established once during initial development and do not require ongoing monitoring