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Metal Impurities Information Request

This document and the attached Identification of Potential Elemental Impurities Statement have been designed and developed by IPEC-Americas to facilitate the exchange of information between manufacturers and users of ingredients used in the formulation of drug products. It is hoped that through completion of the request form and consolidation of the responses, both parties can begin to gain a better understanding of the potential elemental impurity levels for excipients used in drug products in preparation for the ICH Q3D Metal Impurities Guideline (1) (currently a Step 2b document) and compendial requirements in USP General Chapter <232> Elemental Impurities Limits, which is expected to be aligned with the ICH Guideline once final.

The purpose of this request is to solicit information from suppliers of ingredients used in drug products in order to develop an understanding of metals that may be present in these materials. This information will be helpful to users in their assessment of potential metals and their contribution in drug product formulations for compliance to ICH Q3D and USP <232> compendial requirements. Suppliers are encouraged to provide information that may be available to assist their customers in meeting these requirements, which are mandatory for finished drug products. However, users need to recognize that suppliers may not have all of this information readily available. The limits in ICH Q3D do not apply to the excipient. The information in Table A2.2 of the ICH Q3D Guideline is not a compliance limit for the excipient. This table applies to excipients only as it relates to the use of Option 1 to determine the compliance of the drug product to the Permitted Daily Exposure (PDE). This template covers Class 1, 2A, 2B and 3 elements. Class 4 elements are excluded from this template since ICH Q3D did not consider these to be a safety risk and did not establish PDEs for them. There is no compliance aspect for Class 4 elements relevant to compliance with the Q3D Guideline for the finished drug.

Information is also requested regarding the source or type of excipient since this can be an important factor in the assessment of potential metals. For example, an excipient may be a mineral or it can be mineral derived, i.e. a mineral that is further synthetically processed.

The attached format has been developed by IPEC-Americas to facilitate the exchange of information between users and manufacturers. We encourage using this form to ensure consistency in the information provided. However, if your company has already developed information related to this topic and you have an information sheet or other document which can answer these questions adequately, please forward that document instead of filling out this form.

Page 1 Product Names or Codes Supplied to [COMPANY NAME]:

Please list all products purchased from the supplier in this section. Only one form should be sent to the supplier. If the answers are different for different products produced from that supplier, the supplier can attach a list of the products covered by each form or just fill out one form that would cover an entire manufacturing site if that is appropriate based on the material they produce. (1) ICH Q3D Guideline for Elemental Impurities, Step 2b version, July 26, 2013 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step2b.pdf

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