4. REPORTING DEGRADATION PRODUCTS CONTENT OF BATCHES

Analytical results should be provided in the registration application for all relevant batches of the new drug produc used for clinical , safety , and stability testing .1 ) , and total degradation products observed in the relevant batches of the new drug product should be reported with the analytical procedures indicated Below 1.0%, the results should be reported to the numbe of decimal places ( e . g . .If a higher reporting threshold is proposed , it should be fully justified .