ICH Q3D Elemental Impurities Calculator

Product Name:

Route of Administration:

Oral Parenteral Inhalation

Maximum Daily Dose (g/day):

Option 1: Standard Limits

For daily doses ≤ 10g (Table A.2.2)

Option 2a: Custom Daily Dose

Calculate: PDE ÷ Daily Dose

Option 2b: Component Analysis

Component-by-component assessment

Option 3: Finished Product

Direct product testing

Element Selection & Risk Assessment

Selected: 0 elements

Select elements and enter daily dose to see calculations

Complete the setup above, then calculate limits to see concentration tables here.