5. REPORTING IMPURITY CONTENT OF BATCHES

Analytical results should be provided in the application fo all batches of the new drug substance used for clinical , safety and stability testing , as well as for batches representative o the proposed commercial process .1 ) and tota impurities observed in these batches of the new drug substance should be reported with the analytical procedures indicated Below 1.0%, the results should be reported to two decima places ( e . g . , 0.06%, 0.13%) .If a higher reporting threshold is proposed , it should be fully justified .