Benzyl Alcohol, N.F. Benzyl Alcohol

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1 100 Matsonford Rd., Suite 200 Radnor, PA Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Product Description Macron Fine Chemicals 1403, N.F. J.T.Baker J.T.Baker J.T.Baker J.T.Baker , N.F. Multi-Compendial, N.F., N.F. Multi-Compendial, N.F. Multi-Compendial MOC* R R R R R *MOC = Management of Change Section 2 Manufacturing, Packaging and Releasee Site Information The products in Section 1 are manufactur red according to current Good Manufacturing Practices (cgmps) as set forthh by International Pharmaceutical Excipients Council (IPEC) guidelines. A number of the cgmp produced products thatt are sold by Avantor Performance Materials, LLC. may not be originally manufactured at our sites. However, we perform the analytical and stability testing for these products and repackagee the products where applicable. With ISO and cgmp procedures in place at our facilities we can ensure, and take complete responsibilityy for, the traceability and quality of the finished, packaged product that we offer. The original manufacturer and address will bee referenced on the Certificate of Analysiss as an alpha or alpha-numeric manufacturer code rather than listing the full name and address. This practice is compliant with both ICH Q7 Good Manufacturing Guidance for Active Pharmaceu utical Ingredients (APIs) and IPEC guidelines and it meets cgmp requirements. For instructions to decipher the manufacturer reference code please consult our website. Instructions can be found Page 1 of 12

2 in the Ask Avantor Q&A Center of the customer support section of our web site or by directly linking to vantor.com Keyword: : Manufacturer Code. Section 3 Physical/Chemica Information CAS #: Manufacturing Process: Synthesis Raw Material Origin: Chemical Section 4 Regulatory Information Compendial Compliance: Please see the current product specifications at DMF: Avantor Performancee Materials, LLC does not carry a Drug these products. Master File for BSE/TSE Status, all codes: The subject materials are manufactured from raw materials that contain NO animal parts, products, and/or by-products nor do they come in contact with animal parts, products, and/or by-products. Therefore the risk of BSE/TSE is considered negligible. BSE/TSE Status J.T. Baker 9421, 9041, and 9039: These products are not produced with any bovine, ovine, or caprine tissue as classified per EMA/410/01 rev.3; therefore, the risk of BSE/TSE risk is considered negligible. Allergen/Hypersensitivities Information: The products listed do not contain cereals containing gluten (i.e. wheat, rye, oats, barley, spelt, kamut or their hybridized strains), malt, triticale, gluten, other grains, corn, soy, soybeans, eggs, yeast, canola, milk, dairy products, fish, crustacean shellfish, seafood products, tree nuts, peanuts, nut products ( i.e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illiniesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa) ), Pistachio nut (Pistaciaa vera), Macadamia nut and Queensland nut (Macadamia ternifolia)), seed Page 2 of 12

3 products (sesamee seeds and products thereof) ), natural grape products, natural flavors, artificial flavors, celery, mustard, lactose, sulfites, elemental sulfur, preservatives, lupine and products thereof, MSG, disodium guanylate/inosinate, artificial sweeteners, phenylalanine, additives, colorants, dyes, or natural rubber (latex). These products are manufactured using cgmp guidelines which provide controls that allow no potential for cross contamination of any allergens or other products. GMO Information: The subject materials, including any raw materials and processing aids, are NOT subject to genetic modification. Residual Solvents/ Organic Volatile Impurities (OVI) Information: Product code: 1403, 9040, 9421 The Class 1 residual solvent Benzene is likely to bee present below 2 ppm. The actual analysiss is reported for each lot. The Class 2 solvent Toluene is likely to be presentt and is process controlled to <30 ppm. No other Class 1, 2 or 3 residual solvents aree likely to be present. Residual Solvents/ Organic Volatile Impurities (OVI) Information: Product Code: 9039, 9041 The subject materials (all lots) comply with the requirements of the ICH Q3C Residual Solvents Guideline and USP<467>Residual Solvents. No Classs 1, 2, 3 or other solventss are used or produced in the manufacturing or purification of the product. Elemental Impurities: Please see attached summary for Elemental Impurity information for listed products. Information for 9041 is supplied on product Certificate of Analysis. Kosher Status: The subject materials are not Kosher Certified. Please refer to the customer support section of our website for ourr most up to date listing of Kosher products. ( Keyword: Kosher) Halal Status: The subject materials are not Halal Certified. Please refer to the customer support section of our website for our most up to date listing of Halal products. ( Keyword: Halal) GRAS Status: Not Assessed Page 3 of 12

4 Section 5 Miscellaneous Product Information Certificate of Analysis Date Format: The Manufactured Date and Expiration/Retest Date on the C of A are reported as YYYY/MM/DDD from our ERP system effective April 30, For example, thee Manufactured Date for October 1, 2012 would be reported as 2012/10/01. Prior to ERP implementation, the Release Datee on the C of A was reported as MM/DD/YYYY. For example, the Release Date for October 1, 2012 would have been reported as 10/01/ /2012. Lot Numbering System and Batch Description: Pleasee refer to the customer support section of our website for information concerning our lot/batch numbering system. ( Keyword: Lot Number) Batch Definition: A batch is a homogeneous unit of production; each batch from one single batch of the source supplier. of is Shelf Life Information: If a product has an assigned expiration or retest period, the date will appear on the certificate of analysis. For products thatt do not have assigned dates please contact Technical Support through the customer support section of our website for our product stability profiles. ( Keyword: Expiration) Management of Change: Please refer to the customerr support section of our website for information concerning our Managementt of Change program. ( Keyword: MOC) Country of Origin Statement: Country of Origin is indicated on the product Certificate of Analysis. Please contactt our Tradee Compliance if you require further documentation (Trade.Compliance@Avantorinc.com). Storage Requirements: Please refer to the product Certificate of Analysis/Product Specifications. In the absence of specific storage conditions listed on the Avantor specification sheet or certificate of analysis, our products are to be stored in ambient conditions of temperature and humidity. We do not formally tie any specific temperature or humidity range with thee ambient storage designation, but Page 4 of 12

5 an example of a common temperature interpretation is C. Our products are also packaged to protect from the normal variation in humidity during storage and shipment. Further handling and storage information may be found in Section 7 of the product SDS sheet. Section 6 Revision History Rev. 0; Oct. 1, 2007 IPEC EIP format Rev. 1; Feb. 18, 2008 Deleted product 1403 Rev. 2; Sept. 30, 2008 Section 4: Clarified Residual Solvents statement. Added reference to USP Chapter <467>. Rev. 3; Dec. 16, 2008 Section 4: Revised Residual Solvents statement per MOC- QUAL Section 7: Updated telephone numbers for Technical Service Manager and Director of Customer Service. (KES) Rev. 4; March 1, 2011 Entire document: new letterhead and changed all references of Solv IT Center or AskMBI to AskAvantor. Updated website links for new website; Section 7: updated contact information. Added Residual Metallic Catalysts statement.(mch) Rev. 5; April 19, updatedd Section 2, added MOC codes (MCH) Rev. 6; Mar 12, HDQ address change; Section 1: Addedd Macron 1403; Section 4: added add l allergens as listed in EU Directive 2003/89/EC; updated Residual Solvents and Residual Metallic Catalysts statement; separated Kosher/Halal status and added certification statement; Section 5: Added COA Date Format statement; added Manageme ent of Change information; Section 7: removed contact list table and added CS/TS contact information. (JDR) Rev. 7: March 21, 2013: Updated document revision in footer.. Missed in rev. 6. (MCH) Rev. 8: May 21, Updated Residual Solvents statements; statements were incorrectly updated with Rev. 6. (MCH) Rev. 9: October 8, 2015 Section 4: Updated BSE/ /TSE statement for code 9421 to include reference to EMA guideline.(mch) Rev. 10: November 30, 2017 Update to new format. Section 4: Removed Residual Metallic Catalysts and addedd Elemental Impurity Statements. (PT) Rev 11: November 16, 2018 Entire document: new letterhead (logo & headquarters address, updated com ;Section 1: Added code Section 4: restored BSE/TSE statement for code 9421 and added code 9039.(MCH) Page 5 of 12

6 This electronic document is valid without a signature. Section 7 Contact Information Customer Service Phone: (outside U.S.) Fax: CS.Specialis st@avantorinc.com Technical Service Phone: (outside U.S.) Fax: Technical.Se ervice@avantorinc.com While the above information is providedd in good faith and believed to be accurate as of the date provided, Avantor Performance Materials ( Avantor ) makes no representations or warranties as to thee accuracy or completeness of such information. All Avantor products are subject to Avantor s terms and conditions of sale including the limitations of liability contained therein and any contrary terms and conditions are expressly rejected. As Avantor has no control over purchasers uses of its products, Avantor expressly disclaims all liability with respect too same. The most current revision of this document is maintained on our website. Reviews and revisions are performed as warranted due to product changes or as part of the supplier audit cycle Trademarks are owned by Avantor Performance Materials, LLC. or its affiliates unless otherwise noted Avantor Performance Materials, LLC. Page 6 of 12

7 100 Matsonford Rd., Suite 200 Radnor, PA Material Name: Product codes: 9039 Date: November 3, 2016 Source/Type of Excipient: Mineral; Mineral derived; Plant; Plant derived; Synthetic; Fermentation derived Other (explain): Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or Range) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Arsenic (inorganic) As 1 Cadmium Cd 1 Mercury (inorganic) Hg 1 Lead Pb 1 Cobalt Co 2A Nickel Ni 2A Vanadium V 2A Page 7 of 12

8 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or Range) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Silver Ag Gold Au Iridium Ir Osmium Os Palladium Pd Platinum Pt Rhodium Rh Ruthenium Ru Selenium Se Thallium Tl Barium Ba 3 Chromium Cr 3 Copper Cu 3 Lithium Li 3 Page 8 of 12

9 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or Range) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Molybdenum Mo 3 Antimony Sb 3 Tin Sn 3 Reference: ICH Q3D Guideline for Elemental Impurities, Step 4 version, September 2014 David L. Cugini, Sr. QA Analyst Prepared by the Technical Servicee Department Avantor Performance Materials, LLC Avantor Performance Materials, LLC provides the information contained herein in good faith but makes no representations or warranties, either expressed or implied, including without limitation any warranties of merchantability or fitness for a particular purpose with respect to the information set forthh herein or the product(s) to which the information refers. Accordingly, Avantor Performance Materials, LLC will not be responsible for damages resulting from the use of or reliance upon this information. Trademarks are owned by Avantor Performance Materials, LLC or its affiliates unless otherwise noted Avantor Performance Materials, LLC Page 9 of 12

10 Material Name: Product codes: 9421, 9040, 1403 Date: May 3, 2016 Source/Type of Excipient: Mineral; Mineral derived; Plant; Plant derived; Synthetic; Fermentation derived Other (explain): Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or Range) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Arsenic (inorganic) As 1 Cadmium Cd 1 Mercury (inorganic) Hg 1 Lead Pb 1 Cobalt Co 2A Nickel Ni 2A Vanadium V 2A Silver Ag Page 10 of 12

11 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or Range) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Gold Au Iridium Ir Osmium Os Palladium Pd Platinum Pt Rhodium Rh Ruthenium Ru Selenium Se Thallium Tl Barium Ba 3 Not Tested Chromium Cr 3 Copper Cu 3 Lithium Li 3 Not Tested Molybdenum Mo 3 Page 11 of 12

12 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or Range) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Antimony Sb 3 Not Tested Tin Sn 3 Not Tested Reference: ICH Q3D Guideline for Elemental Impurities, Step 4 version, September 2014 David L. Cugini, Sr. QA Analyst Prepared by the Technical Servicee Department Avantor Performance Materials, LLC Avantor Performance Materials, LLC provides the information contained herein in good faith but makes no representations or warranties, either expressed or implied, including without limitation any warranties of merchantability or fitness for a particular purpose with respect to the information set forthh herein or the product(s) to which the information refers. Accordingly, Avantor Performance Materials, LLC will not be responsible for damages resulting from the use of or reliance upon this information. Trademarks are owned by Avantor Performance Materials, LLC or its affiliates unless otherwise noted Avantor Performance Materials, LLC Page 12 of 12