3. RATIONALE FOR THE REPORTING AND CONTROL OF IMPURITIES

The applicant should summarise the actual and potentia impurities most likely to arise during the synthesis , purification and storage of the new drug substance .This summary should be based on sound scientific appraisal of the chemical reactions involved in the synthesis , impurities associated with raw materials that could contribute to the impurity profile of the new drug substance .The control of residues of the solvents used in the manufacturing process for the new drug substance should be discussed and presented according to the ICH Q3C Guideline for Residual Solvents .