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1 Sodium Citrate, Dihydrate Product egulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Product Description MOC * code J.T.Baker J.T.Baker Sodium Citrate, Dihydrate, Granular, U.S.P. Sodium Citrate, Dihydrate, Granular, U.S.P. J.T.Baker J.T.Baker J.T.Baker Macron Fine Chemicals Macron Fine Chemicals Macron Fine Chemicals CH Sodium Citrate, Dihydrate, Granular U.S.P. - F.C.C. Sodium Citrate, Dihydrate, Powder U.S.P. - F. C.C. Sodium Citrate, Dihydrate, Granular, C.H.P., Multi- Compendial Sodium Citrate Dihydrate Crystalline USP - GenA Sodium Citrate, Dihydrate, Crystal U.S.P. - F.C.C. Sodium Citrate, Dihydrate, Crystal USP - GenA *MOC = Management of Change Section 2 Manufacturing, Packaging and eleasee 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 ev. 6; December 14, 2018 Page 1 of 13 SODIUM CITATE, DIHYDATE

2 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. Instructionss can be found 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: Fermentatio on aw Material Origin: Plant Section 4 egulatory 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: The subject materials are manufactured from raw materials that contain NO animal parts, products, and/or by-products norr do they come in contact with animal parts, products, and/or by-products. Allergen/Hypersensitivities Information: The sodium citrate products are produced from fermentationn of carbohydrates that may bee derived from corn starch and beet molasses. The products listed do not contain cereals containing gluten (i.e. wheat, rye, oats, barley, spelt, kamut or their hybridizedd strains), malt, triticale, gluten, other grains, soy, soybeans, eggs, 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 (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia)), seed products (sesame seeds and products thereof), natural grape products, natural ev. 6; December 14, 2018 Page 2 of 13 SODIUM CITATE, DIHYDATE

3 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: Codes 3647, 3648, 3649, 3650, 0634, CH07: Per our supplier, the starch-based fermentation feedstock used to make these products is made from non-segregated corn (maize), which thereforee may contain material from genetically modified crops. However, tests on these products using Polymerase Chain eaction and HPLC saccharide analysis have to date all tested negative for both genetically modified material and residue of the original feedstock. In addition, thesee products are produced by a conventional micro-organism. Food additives producedd by conventional micro-organisms are considered not to fall within the scope of egulation 1829/ Codes 0734, 7773: Our supplier does not usee genetically modified production strains* for the manufactur re these products and works together solely with raw material suppliers who can exclude the processing of genetically modified organisms. They purchase raw materials upon a NON-GMO agreement, if they are derived from crops for whichh genetically modifiedd varieties exist. *no GMO in the meaning of Directive 90/219/ /EC and as amended in Directive 2001/18/ /EC esidual Solvents/Organic Volatile Impuritiess (OVI) Information: The subject materials (all lots) comply with the requirementss of the ICH Q3C esidual Solvents Guideline and USP<467>esidual Solvents. No Class 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 for listed products. Kosher Status: Certified Kosher Pareve for year-round use. Please refer to the customer support section of our website for ourr most up to date listing of Kosher products. ( Keyword: Kosher) ev. 6; December 14, 2018 Page 3 of 13 SODIUM CITATE, DIHYDATE

4 Halal Status: J..T.Baker 3650 is Halal Certified. Please refer to the customer support section of our website for our most up to date listing of Halal products. ( Keyword: Halal) GAS Status: The United States Food and Drug Administration (FDA) have acknowledged that Sodium Citrate is a Substance Generally ecognized as Safe (GAS) in foods when used in accordance with the requirements and limitations per 21 CF parts Section 5 Miscellaneous Product Information Certificate of Analysis Date Format: The Manufactured Date and Expiration/etest Date on the C of A are reported as YYYY/MM/DDD from our EP system effective April 30, For example, thee Manufactured Date for October 1, 2012 would be reported as 2012/10/01. Prior to EP implementation, the elease Datee on the C of A was reported as MM/DD/YYYY. For example, the elease 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 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) Nutritional/Supplement Facts Labeling: Bulk food chemicals that are intendedd for the use in manufacturing of finished food products or for products that are to be processed, labeled, and/or repacked at a sitee other than wheree it s originally processed or packed, are exempt from the Nutrient Contentt Evaluation and Nutrient Labeling equirements. (21 CF 101.9(j)( (9)) ev. 6; December 14, 2018 Page 4 of 13 SODIUM CITATE, DIHYDATE

5 Organic Status: The products listed in Section 1 are not certified as organic. However, to the best of our knowledge, the product is nott producedd using Ionizing adiation as described in 21 CF or Sewage Sludge as described in 7 CF Section Management of Change: Please refer to the customerr support section of our website for 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 equirements: 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 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 may be found in Section 7 of the product SDS sheet. Section 6 evision History ev. 0; Oct. 1, 2007 IPEC EIP format ev. 1; Sept. 30, 2008 Section 4: updated residual solvents ev. 2; July 18, 2011 Entire document: new letterhead, and changed all references of Solv IT Center or AskMBI to AskAvantor. Updated website links for new website; Section 1: Mallinckrodt brand name updated to Macron; added MOC codes; Section 2: added GMP statement; Section 4: expanded Allergens list; added esidual Metallic Catalystss and GAS Status statements ; Section 5: Added Nutritional and Organic Status Statements; Section 7: updated contact ; minor formatting. (PH/MCH) ev. 3;..Nov. 21, 2012 Entire document: headquarters address changed; minor formatting Section 4: added USP compendial compliance; added reference to metal reagents in esidual Metallic Catalysts statement; separated Kosher/Halal status and added certification statement Section 5: added Management of Change ; Added COA Date Format statement Section 7: removed contact list table and added CS/TS contact. (MCH) ev. 6; December 14, 2018 Page 5 of 13 SODIUM CITATE, DIHYDATE

6 ev. 4; Jan. 16, Corrected Allergen and updated GMO to reflect supplier. (MCH) ev. 5: Feb. 6, 2015 Section 4: Updated GMO statement to match supplier s statement for codes 3647, 3648, 3649, 3650, (MCH) ev 6; December 14, 2018 Entire document: new letterhead (logo & headquarters address, updated com Section 1: Added code CH07; Section 4: emoved esidual Metallic Catalyst statement, replaced with Elemental Impurities.; Section 5: added Storage equirement, Batch Definition, and Country of Origin Statements (MCH) 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 is providedd in good faith and believed to be accurate as of the date provided, Avantor Performance Materials ( Avantor ) makes no reations or warranties as to thee accuracy or completeness of such. 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. eviews 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. ev. 6; December 14, 2018 Page 6 of 13 SODIUM CITATE, DIHYDATE

7 100 Matsonford d., Suite 200 adnor, PA Material Name: Sodium Citrate, Dihydrate Product codes: 3647, 3648, 3649, 3650, CH07 Date: April 8, 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 ange) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Arsenic (inorganic) As ICP-MS (ML=0.05 ppm) Cadmium Cd ICP-MS (ML=0.05 ppm) Mercury (inorganic) Hg ICP-MS (ML=0.05 ppm) Lead Pb ICP-MS (ML=0.05 ppm) Cobalt Co 2A ICP-MS (ML=0.05 ppm) Nickel Ni 2A 0.08 ppm ICP-MS (ML=0.05 ppm) ev. 6; December 14, 2018 Page 7 of 13 SODIUM CITATE, DIHYDATE

8 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or ange) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Vanadium V 2A ICP-MS (ML=0.05 ppm) Silver Ag ICP-MS (ML=0.05 ppm) Gold Au ICP-MS (ML=0.05 ppm) Iridium Ir ICP-MS (ML=0.05 ppm) Osmium Os ICP-MS (ML=0.05 ppm) Palladium Pd ICP-MS (ML=0.05 ppm) Platinum Pt ICP-MS (ML=0.05 ppm) hodium h ICP-MS (ML=0.05 ppm) uthenium u ICP-MS (ML=0.05 ppm) Selenium Se ICP-MS (ML=0.05 ppm) Thallium Tl ICP-MS (ML=0.05 ppm) Barium Ba 3 ICP-MS (ML=0.05 ppm) Chromium Cr 3 ICP-MS (ML=0.05 ppm) Copper Cu 3 ICP-MS (ML=0.05 ppm) Lithium Li 3 0.1ppm ICP-MS (ML=0.05 ppm) ev. 6; December 14, 2018 Page 8 of 13 SODIUM CITATE, DIHYDATE

9 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or ange) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Molybdenum Mo ppm ICP-MS (ML=0.05 ppm) Antimony Sb 3 ICP-MS (ML=0.05 ppm) Tin Sn 3 ICP-MS (ML=0.05 ppm) eference: 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 contained herein in good faith but makes no reations or warranties, either expressed or implied, including without limitation any warranties of merchantability or fitness for a particular purpose with respect to the set forthh herein or the product(s) to which the refers. Accordingly, Avantor Performance Materials, LLC will not be responsible for damages resulting from the use of or reliance upon this. Trademarks are owned by Avantor Performance Materials, LLC or its affiliates unless otherwise noted Avantor Performance Materials, LLC ev. 6; December 14, 2018 Page 9 of 13 SODIUM CITATE, DIHYDATE

10 100 Matsonford d., Suite 200 adnor, PA Material Name: Sodium Citrate, Dihydrate Product codes: : 0734, 7773 Date: May 1, 2017 Source/Type of Excipient: Mineral; Mineral derived; Plant; Plant derived; Synthetic; Fermentation derived Other (explain): No ICH Q3D elementals are intentionally added to this product. esults are based on a minimum of 3 commercially ested batches. Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or ange) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Arsenic (inorganic) As ICP-OES Cadmium Cd ICP-MS (ML=0.1 ppm) Mercury (inorganic) Hg <0.01 ppm ICP-MS (ML=0.01 ppm) Lead Pb ICP-MS (ML=0.05 ppm) Cobalt Co 2A <0.2 ppm ICP-MS (ML=0.2 ppm) Nickel Ni 2A ICP-MS (ML=0.1 ppm) Vanadium V 2A <0.2 ppm ICP-MS (ML=0.2 ppm) ev. 6; December 14, 2018 Page 10 of 13 SODIUM CITATE, DIHYDATE

11 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or ange) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Silver Ag Not expected to be ICP-MS (ML=0.05 ppm) Not used in production Gold Au Not expected to be ICP-MS (ML=0.05 ppm) Not used in production Iridium Ir ICP-MS (ML=0.1 ppm) ; not used in production, but tested for Osmium Os Not expected to be ICP-MS (ML=0.05 ppm) Not used in production Palladium Pd Not expected to be ICP-MS (ML=0.05 ppm) Not used in production Platinum Pt ICP-MS (ML=0.1 ppm) ; not used in production, but tested for hodium h ICP-MS (ML=0.1 ppm) ; not used in production, but tested for uthenium u ICP-MS (ML=0.1 ppm) ; not used in production, but tested for Selenium Se <0.5 ppm ICP-MS (ML=0.5 ppm) ; not used in production, but tested for ev. 6; December 14, 2018 Page 11 of 13 SODIUM CITATE, DIHYDATE

12 Elemental Impurity Class Likely to be Present If Known, Please Identify the Expected Concentration /Units (or ange) Analytical Method Used (and Limit of Detection if Available) Comments regarding source of (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Thallium Tl Not expected to be ICP-MS (ML=0.05 ppm) Not used in production Barium Ba 3 Not expected to be Chromium Cr 3 Not expected to be Copper Cu 3 Not expected to be Lithium Li 3 Not expected to be Molybdenum Mo 3 Not expected to be Antimony Sb 3 Not expected to be Tin Sn 3 Not expected to be eference: ICH Q3D Guideline for Elemental Impurities, Step 4 version, September 2014 ev. 6; December 14, 2018 Page 12 of 13 SODIUM CITATE, DIHYDATE

13 David L. Cugini, Sr. QA Analyst Prepared by the Technical Servicee Department Avantor Performance Materials, LLC Avantor Performance Materials, Inc provides the contained herein in good faith but makes no reations or warranties, either expressed or implied, including without limitation any warranties of merchantability or fitness for a particular purpose with respect to the set forthh herein or the product(s) to which the refers. Accordingly, Avantor Performance Materials, LLC will not be responsible for damages resulting from the use of or reliance upon this. Trademarks are owned by Avantor Performance Materials, Inc. or its affiliates unless otherwise noted Avantor Performance Materials, LLC. ev. 6; December 14, 2018 Page 13 of 13 SODIUM CITATE, DIHYDATE