(i ° BASF Stay Dr. Wolf-Ruediger Schlag ENS/HRP Tol. +49 621 6027702 wolt-ruediger.schtag@basf.com 15 Mar 2017 Dear Valued Customer, BASF is pleased to provide the attached elemental impurity information including data on three individual, ‘commercial production batches in analogy to the ICH Q3D approach. In order to fulfill your need for excellence in customer support, BASF has chosen to invest significant resources into screening and validating of analytical methods for all ICH Q3D elements in class 1, 2A, and 3. Any class 2B elements which are intentionally added in BASF's manufacturing process are tested as well. All data were obtained via a validated ICP-MS method. The attached analytical report is intended to support your risk assessment and control strategy for the concemed finished drug product. In certain cases, this data could enable the use of a component approach to testing, although ICH Q3D places the responsibilty of obtaining elemental impurity data on finished product manufactures - not API or excipient suppliers. We are convinced that our elemental impurity information provides a significant added-value and again demonstrates BASF's commitment to being a leading supplier to the pharma industry. We sincerely appreciate your business and look forward to continuing to service your needs in the future. Should you have any questions about this data or elemental impurity requirements, please feel free to contact me or your account manager. Sincerely, BASF SE Nutrition and Health Y). Blob i.V. Dr. Dominik Odenbach Director Global Regulatory & External Affairs Global Segment Management Pharma Solutions ‘This document and any information provided herein is for your guidance only. Al information is given in good faith and is based on sources believed to be reliable and accurate at the date of publication ofthis document. This document shall be valid for 18 months after the date of issue or until superseded by a later version, whichever occurs fst ‘SELLER MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, BY FACT OR LAW, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE 10f3Vitamin E-Acetate (DL-alpha-tocophery! aceta Element (Method: ICP-MS) BASF contract no, 1401422 Cadmium cd Lead Pb Arsenic As. Mercury Hg Cobatt co Vanadium v Nickel Ni Thallium 1 Gold Au Palladium Pd Iridium, i Osmium Os Rhodium, Rh Ruthenium Ru Selenium Se Silver Ag Platinum Pt Lithium u ‘Antimony Sb Barium Ba Molybdenum Mo Copper cu Tin Sn Chromium cr Class 4 1 1 1 20 2A 2A 2B 2B 2B 2B 2B 28 28 batch 00384377L0 [mg/kg] _ <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 not measured not measured not measured not measured not measured not measured not measured not measured not measured not measured <0.3 <03 <03 <0.05 03 <0.3 <0.05 ‘Stating a less-than (<) sign indicates less-than (<) LOG ‘The indication “not measured” means that no testing was performed as the element is not intentionally added in BASF's manufacturing process. batch 00384577LO [mg/kg] <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 ‘not measured not measured not measured not measured not measured not measured not measured not measured not measured not measured <0.3 <0.3 <03 <0.05 <03 <0.3 <0.05 batch 00384677L0 [mgikg} <0.05 <0.05 <0.05 <0,05 <0.05 <0.05 <0.05 not measured not measured not measured not measured not measured not measured not measured not measured not measured not measured <0.3 <0.3 <0.3 <0.05 <0.3 <03 <0.05 20f3The concentration of the tested elements in Vitamin E-Acetate (DL-alpha-tocopheryl acetate) were below the parenteral concentration limit indicated in Table A.22 of ICH Q3D. Please note that references are explicitly made to the concentration limit and does not automatically imply that the product is intended for parenteral use. Please note that no elements of Table A.2.2 of the aforementioned guideline have been intentionally added in BASF’s manufacturing process of Vitamin E-Acetate (DL-alpha-tocopheryl acetate). We ensure compliance of our pharmaceutical ingredients with all relevant regulatory requirements for metal impurities such as current versions of Ph. Eur. and USP as well as EMA Guideline on the Specification Limits for Residues of Metal Catalysts or Metal reagents, (EMEA/CHMP/SWP/4446/2000). The analytical data above will also be part of BASF's risk assessment fo control the potential of elemental impurities. 30f3