Coalition Comments to USP regarding Recommendations for Inclusion of Bioaccessible Methodologies in General Chapter <233> and the Development of a PDE Calculator for Industry Risk Assessment using ICH Q3D Option 2B

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Wednesday, October 30, 2013

The Coalition for Rational Implementation of the USP Elemental Impurities Requirements  provided the attached comments to USP which are related to the sample preparation methods in USP General Chapter <233>.  For your reference   a PDE Calculator tool that the Coalition has developed to help companies perform risk assessments on their drug product formulations is also provided.

Please use the links below:

Coalition Letter to USP-PDE Calculator & Bioaccessibility Position Paper 

Coalition Position Paper - Risk Based Analysis of Elemental Impurities

Copy of Elemental Impurity Daily Intake Calculator

Instructions for PDE Calculator for Elemental Impurities