Reference Center

Elemental Impurities Template

Download Links:
Letter PDE Calculator Instructions
Template Daily Intake Calculator

Letter & Template

IPEC Americas, with input from the Coalition for Rational Implementation of Elemental Impurities Requirements, has developed a standardized letter and template that pharmaceutical companies can use to collect available information from their suppliers regarding elemental impurities in excipients.  

The letter can be customized by the sender to include the product names, contact information, etc.  The template provides a standardized format to collect information relative to Class 1, 2A, 2B and 3 elements in the ICH Q3D Step 2b proposed guideline.  Class 4 elements were not included since these were not considered by ICH Q3D to be a safety risk and no PDEs were established.  Information on the excipient source is included as this can be a key factor in risk assessment.  

IPEC-Americas encourages excipient suppliers to populate this template with information they may have available for their products as an alternative to completing individual forms received from customers.  Pharmaceutical companies should also use this letter and template as a means to collect information from suppliers on the excipients they purchase.

This template provides an efficient user - supplier format for communication of what information is available.  This information is a key part of the pharmaceutical company's risk assessment process to determine their next steps to plan for eventual implementation of the final guideline's limits of these elements in the finished drug.  It is also important to stress that many excipient suppliers may not have information on the presence of many of the elements listed in ICH Q3D. This information can then be used by the user to identify their plans for testing and risk assessment.  

Permitted Daily Exposure (PDE) calculator

The Coalition for Rational Implementation of Elemental Impurities Requirements has developed a Permitted Daily Exposure (PDE) calculator, including instructions and examples for how to calculate total elemental impurity content for the different drug forms covered by the ICH Q3D Step 4 Guideline (targeted at new oral, parenteral and inhaled drug products).  A link to both the PDE calculator (Excel workbook) and instructions can be found at the top of this page.