the vantor.com CAS #: Master File Information these products. molasses. avellana), (Corylus Page 2 of 14
|
|
- Noel Booker
- 5 years ago
- Views:
Transcription
1 100 Matsonford d., Suite 200 adnor, PA 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. ev. 6; December 14, 2018 Page 1 of 14 SODIUM CITATE, DIHYDATE
2 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. 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 ev. 6; December 14, 2018 Page 2 of 14 SODIUM CITATE, DIHYDATE
3 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 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 information for listed products. ev. 6; December 14, 2018 Page 3 of 14 SODIUM CITATE, DIHYDATE
4 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) 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 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) 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 ev. 6; December 14, 2018 Page 4 of 14 SODIUM CITATE, DIHYDATE
5 processed or packed, are exempt from the Nutrient Contentt Evaluation and Nutrient Labeling equirements. (21 CF 101.9(j)( (9)) 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 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 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 information 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 information 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 information; 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 ev. 6; December 14, 2018 Page 5 of 14 SODIUM CITATE, DIHYDATE
6 and added certification statement Section 5: added Management of Change information; Added COA Date Format statement Section 7: removed contact list table and added CS/TS contact information. (MCH) ev. 4; Jan. 16, Corrected Allergen information and updated GMO information to reflect supplier information. (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 information 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 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. eviews and revisions are performed as warranted due to product changes or as part of the supplier audit cycle ev. 6; December 14, 2018 Page 6 of 14 SODIUM CITATE, DIHYDATE
7 Trademarks are owned by Avantor Performance Materials, LLC. or its affiliates unless otherwise noted Avantor Performance Materials, LLC. ev. 6; December 14, 2018 Page 7 of 14 SODIUM CITATE, DIHYDATE
8 100 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 information (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) 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) ev. 6; December 14, 2018 Page 8 of 14 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 information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) 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) 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) ev. 6; December 14, 2018 Page 9 of 14 SODIUM CITATE, DIHYDATE
10 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 information 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 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 ev. 6; December 14, 2018 Page 10 of 14 SODIUM CITATE, DIHYDATE
11 100 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 information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Arsenic (inorganic) As <0.1 ppm ICP-OES Manufacturer supplied data Cadmium Cd <0.1 ppm ICP-MS (ML=0.1 ppm) Manufacturer supplied data Mercury (inorganic) Hg <0.01 ppm ICP-MS (ML=0.01 ppm) Manufacturer supplied data Lead Pb ICP-MS (ML=0.05 ppm) Manufacturer supplied data Cobalt Co 2A <0.2 ppm ICP-MS (ML=0.2 ppm) Manufacturer supplied data Nickel Ni 2A <0.1 ppm ICP-MS (ML=0.1 ppm) Manufacturer supplied data Vanadium V 2A <0.2 ppm ICP-MS (ML=0.2 ppm) Manufacturer supplied data Silver Ag Not expected to be ICP-MS (ML=0.05 ppm) Not used in production ev. 6; December 14, 2018 Page 11 of 14 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 information (i.e.; number of lots ested, frequency of testing, process understanding, etc.) Gold Au Not expected to be ICP-MS (ML=0.05 ppm) Not used in production Iridium Ir <0.1 ppm ICP-MS (ML=0.1 ppm) Manufacturer supplied data; 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 <0.1 ppm ICP-MS (ML=0.1 ppm) Manufacturer supplied data; not used in production, but tested for hodium h <0.1 ppm ICP-MS (ML=0.1 ppm) Manufacturer supplied data; not used in production, but tested for uthenium u <0.1 ppm ICP-MS (ML=0.1 ppm) Manufacturer supplied data; not used in production, but tested for Selenium Se <0.5 ppm ICP-MS (ML=0.5 ppm) Manufacturer supplied data; not used in production, but tested for ev. 6; December 14, 2018 Page 12 of 14 SODIUM CITATE, DIHYDATE
13 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 information (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 Not tested for Manufacturer supplied information Chromium Cr 3 Not expected to be Not tested for Manufacturer supplied information Copper Cu 3 Not expected to be Not tested for Manufacturer supplied information Lithium Li 3 Not expected to be Not tested for Manufacturer supplied information Molybdenum Mo 3 Not expected to be Not tested for Manufacturer supplied information Antimony Sb 3 Not expected to be Not tested for Manufacturer supplied information Tin Sn 3 Not expected to be Not tested for Manufacturer supplied information eference: ICH Q3D Guideline for Elemental Impurities, Step 4 version, September 2014 ev. 6; December 14, 2018 Page 13 of 14 SODIUM CITATE, DIHYDATE
14 David L. Cugini, Sr. QA Analyst Prepared by the Technical Servicee Department Avantor Performance Materials, LLC Avantor Performance Materials, Inc provides the information 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 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, Inc. or its affiliates unless otherwise noted Avantor Performance Materials, LLC. ev. 6; December 14, 2018 Page 14 of 14 SODIUM CITATE, DIHYDATE
Sodium Citrate, Dihydrate
Sodium Citrate, Dihydrate Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Product Description MOC* code J.T.Baker 3647 Sodium Citrate, Dihydrate, Granular,
More informationvantor.com CAS #: Master File these products. Information molasses. (Corylus avellana), Page 2 of 13
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 3647 3648 Sodium Citrate, Dihydrate,
More informationCALCIUM CHLORIDE. Product Regulatory Data Sheet
CALCIUM CHLORIDE Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Product Description MOC* code J.T.Baker 1335 Calcium Chloride, Dihydrate, Granular, U.S.P.
More informationSodium Chloride. Product Regulatory Data Sheet
Sodium Chloride Product Regulatory Data Sheet Avantor Performance Materials, Inc. Section 1 Product Information Products Covered Brand Product Code Product Description MOC * Code J.T. Baker 3627 Sodium
More informationSodium Acetate, Anhydrous
Sodium Acetate, Anhydrous Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Product Description MOC* code J.T.Baker 3473 Sodium Acetate, Anhydrous, U.S.P.
More informationProducts Covered. Product. Brand. Code. code. Compendial. J.T.Baker Macron Fine R R. Chemicals. USP - GenAR. Page 1 of 10
100 Matsonford d., Suite 200 adnor, PA 19087 1 855 2822 6867 www.avantorinc.com Magnesium Sulfate Product egulatory Data Sheet Section 1 Product Information Products Covered Brand Product MOC Product Description
More informationZinc Oxide. Product Regulatory Data Sheet. code Macron Fine Chemicals 8824 Zinc Oxide, Powder U.S.P. R
Zinc Oxide Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Product Description MOC* Code code Macron Fine Chemicals 8824 Zinc Oxide, Powder U.S.P. R *MOC = Management
More informationSucrose. Product Regulatory Data Sheet. Products Covered : Brand Product Code Product Description MOC* J.T.Baker 6321 Sucrose NF, Multi-Compendial R
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 6321 NF, Multi-Compendial R Section 2 Manufacturing, Packaging and Release
More informationSodium Chloride. Product Regulatory Data Sheet
Sodium Chloride Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T. Baker 3627 Sodium Chloride, Granular, U.S.P., Multi-Compendial
More informationHydrochloric Acid. Product Regulatory Data Sheet
Section 1 Product Information Products Covered Brand Product Code Hydrochloric Acid Product Description Product Regulatory Data Sheet J.T.Baker 0319 Hydrochloric Acid, 5.0N Solution Biotech Reagent R J.T.Baker
More informationL-Cysteine Hydrochloride, Monohydrate
L-Cysteine Hydrochloride, Monohydrate Product Regulatory Data Sheet Avantor Performance Materials, Inc. Section 1 Product Information Products Covered Brand Product Code Product Description J.T.Baker 2071
More informationProducts Covered. Product. MOC * code. Brand. Code. J.T.Baker J.T.Baker Macron Fine. originally perform. and quality of offer. the
100 Matsonford Rd., Suite 200 Radnor, PA 19087 1 855 2822 6867 www.avantorsciences.com Magnesium Chloride Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand J.T.Baker J.T.Baker
More informationEdetate Disodium. Product Regulatory Data Sheet. Products Covered : Brand Product Code Product Description MOC* J.T.Baker 8994 Edetate Disodium, USP R
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 8994, USP R J.T.Baker 8995, USP, Multi-Compendial R Macron Fine Chemicals
More informationProducts Covered. MOC * code R. Code. originally perform. and quality of offer. the. Page 1 of 10
100 Matsonford Rd., Suite 200 Radnor, PA 19087 1 855 2822 6867 www.avantorinc.com Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Product Description J.T.Baker
More informationAcetic Acid. Product Regulatory Data Sheet. MOC Product Description Code
Acetic Acid Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product MOC Product Description Code code J.T.Baker 0321 Acetic Acid 80% Solution Biotech Regent R Macron
More informationGlycine. Product Regulatory Data Sheet. Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0581 Glycine U.S.P. - F.C.
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0581 U.S.P. - F.C.C R J.T.Baker 0582, U.S.P. - Multi-Compendial R Section
More informationCitric Acid, Monohydrate
Citric Acid, Monohydrate Product Regulatory Data Sheet Avantor Performance Materials, Inc. Section 1 Product Information Products Covered Brand Product Code Product Description J.T.Baker 0115 Citric Acid,
More informationMagnesium Stearate. Product Regulatory Data Sheet
Magnesium Stearate Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Macron Fine Chemicals Macron Fine Chemicals Product Code 2257 5712 Product Description Magnesium Stearate,
More informationMethylparaben. Product Regulatory Data Sheet. Products Covered : Brand Product Code Product Description MOC* Macron Fine Chemicals
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* Macron Fine Chemicals 6215, NF - GenAR R Section 2 Manufacturing, Packaging and
More informationCitric Acid Monohydrate
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0115 Citric Acid, Monohydrate, Granular, USP, Multi-Compendial R J.T.Baker
More informationSodium Phosphate, Monobasic, Monohydrate
Sodium Phosphate, Monobasic, Monohydrate Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Product Description J.T.Baker 3820 Sodium Phosphate, Monobasic,
More informationPhosphoric Acid. Product Regulatory Data Sheet
Phosphoric Acid Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0240 Phosphoric Acid, N.F., A.C.S. R J.T.Baker 0262
More informationSodium Acetate Trihydrate
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 3461 Sodium Acetate, Trihydrate, Crystal, U.S.P., Multi-Compendial HR
More informationHydrochloric Acid. Product Regulatory Data Sheet
Hydrochloric Acid Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0319 Hydrochloric Acid, 5.0N Solution Biotech Reagent
More informationProducts Covered. MOC * code R. Brand Code. originally perform. and quality of offer. the. vantor.com. Page. 1 of 6
100 Matsonford Rd., Suite 200 Radnor, PA 19087 1 855 2822 6867 www.avantorinc.com Trehalose, Dihydrate Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand J.T.Baker Product
More informationSucrose. Product Regulatory Data Sheet. Products Covered : Brand Product Code Product Description MOC* J.T.Baker 6320 Sucrose NF, Multi-Compendial R
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 6320 NF, Multi-Compendial R Section 2 Manufacturing, Packaging and Release
More informationSucrose. Product Regulatory Data Sheet
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 4074, Crystal, N.F., Multi-Compendial R Macron Fine Chemicals 7723,
More informationLactose, Monohydrate
Lactose, Monohydrate Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Product Description MOC Code J.T.Baker 2249 Lactose, Monohydrate, Powder N.F. R J.T.Baker
More informationThiamine Hydrochloride
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 4110, U.S.P. - F.C.C. R Macron Fine Chemicals 2722, U.S.P. R Section
More informationCitric Acid Anhydrous
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0122 Citric Acid, Anhydrous, Powder, U.S.P. R J.T.Baker 0127 Citric
More informationL-Histidine. Product Regulatory Data Sheet
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 2080, U.S.P. Multi-Compendial R Section 2 Manufacturing, Packaging and
More informationAmmonium Sulfate. Product Regulatory Data Sheet
Ammonium Sulfate Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0798 Ammonium Sulfate, N.F. R J.T.Baker 3523 Ammonium
More informationPotassium Bicarbonate
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* Macron Fine Chemicals Macron Fine Chemicals 6732, Granular, U.S.P. - F.C.C. R
More informationSodium Phosphate Dibasic Heptahydrate
Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 3803 Sodium Phosphate, Dibasic, 7-Hydrate, U.S.P. HR J.T.Baker 3816
More informationPolysorbate 20. Product Regulatory Data Sheet
Polysorbate 20 Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 4112 Polysorbate 20, N.F., Multi-Compendial R J.T.Baker
More informationSodium Carbonate. Product Regulatory Data Sheet
Sodium Carbonate Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand Product Code Description MOC Code J.T. Baker 3605 Sodium Carbonate, Anhydrous, Granular, N.F. - F.C.C.
More informationGELATIN. Product Regulatory Data Sheet. MOC Brand. code J.T.Baker 2124 Gelatin, Powder, NF, Type B R
GELATIN Product Regulatory Data Sheet Section 1 Product Information Products Covered Product MOC Brand Product Description Code code J.T.Baker 2124 Gelatin, Powder, NF, Type B R *MOC = Management of Change
More informationAcetic Acid. Product Regulatory Data Sheet
Acetic Acid Product Regulatory Data Sheet Section 1 Product Information Products Covered : Brand Product Code Product Description MOC* J.T.Baker 0321 Acetic Acid 80% Solution Biotech Reagent R Macron Fine
More informationProducts Covered. MOC * code R R. Brand Code. Polysorbate. originally perform. and quality of offer. the. vantor.com. Page 1 of 9
100 Matsonford Rd., Suite 200 Radnor, PA 19087 1 855 2822 6867 www.avantorinc.com Polysorbate 80 Product Regulatory Data Sheet Section 1 Product Information Products Covered Brand J.T.Baker J.T.Baker Product
More informationSection. Products Covered. MOC * code R. Brand Code. Section. Manufacturing. listing the Q7 Good. Section CAS #: Page. 1 of 6
Product Regulatory Data Sheet 1 Product Information Products Covered Brand J.T.Baker Product Code 4116 Product Description Polysorbate 20, N.F. Multi-Compendial. MOC * code R *MOC = Management of Change
More informationProducts Covered. Section. MOC * code R. Brand Code. Section. Manufacturing. listing the Q7 Good. Section CAS #: Page.
Product Regulatory Data Sheet 1 Product Information Products Covered Brand J.T.Baker Product Code 2093 Product Description L-Tyrosine, U.S.P. Multi-Compendial MOC * code R *MOC = Management of Change 2
More informationAllergen Policy of Martin Bauer S.p.a
Allergen Policy of Martin Bauer S.p.a This policy regarding allergens is part of our HACCP concept within the context of our Quality Management System. In the following our control of the product risks
More information1. Checklist for: Product Developers
1. Checklist for: Product Developers Purpose: Requirements: To help product developers improve the safety of food handling from an allergy perspective. To help consumers with allergies and food intolerances.
More informationProduct Stewardship Information Sheet CH350LN
Product Stewardship Information Sheet CH350LN Contents Product Manufacturer... 2 Food Contact... 2 European Union (EU) Food Contact... 2 US Food and Drug Administration (FDA)... 2 Canada Health Protection
More informationProduct Information Sheet REZISTA HV
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Information Sheet REZISTA DF
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Stewardship Information Sheet CH200LN-02
Product Stewardship Information Sheet CH200LN-02 Contents Product Manufacturer... 2 Food Contact... 2 European Union (EU) Food Contact... 2 US Food and Drug Administration (FDA)... 2 Canada Health Protection
More informationSpecification Sheet Product Description : Iodized Salt Contains ppm Potassium Iodate (
300000001492 1700205110321, 1700205110300, 17002051 Product Description : Iodized Salt Contains 34.0-68.0 ppm Potassium Iodate (20.0-40.0 ppm iodine) Appearance: Crystals Color: White Odor: Bland Solubility
More informationIngredient Statement: Dextrose, Natural & Artificial Flavor, FD&C Red #40 (E129), FD&C Red #3 (E127).
Product Overview: Dry, free flowing granular powder produced with a red color and uniform strawberry flavor and aroma. Strawberry Concentrate Corn Treat Mix is a dextrose base product able to maintain
More informationProduct Information Sheet CLARIA Bliss
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Information Sheet
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationTechnical Data Sheet. General information. Applications, Dosage and Usage. Ingredient List. Product Break Down. All Technical Data
All Technical Data Technical Data Sheet Revision Date: 7/20/2017 Version: 2 Product Code: 509191020 Product Name: RED IRON OXIDE CAS Number: 1309-37-1 E Number: E172 CI Number: CI 77491 Company Name: Sensient
More informationProduct Information Sheet CLARIA Elite
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationPRODUCT SPECIFICATION FOOD INGREDIENTS CALCIUM CHLORIDE 34% (E509) FOOD
1. PRODUCT INDENTIFICATION Supplier product name Supplier product number 11223 Date of issue: 25/02/2016 Replaces: 03/03/2014 Origin Manufacturer Country Certification manufacturer: 1.1 Composition Mineral
More informationProduct Specification
Magnesium Sulphate 1. PRODUCT IDENTIFICATION Supplier product name: Magnesium Sulphate Heptahydrate FCC Origin: Mineral 1.1. Composition Chemical name: Magnesium sulphate heptahydrate, Epsom salt Chemical
More informationProduct Information Sheet
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Information Sheet SODA-LO EXTRA FINE IODIZED
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Specification
1. GENERAL INFORMATION Article number: Product demination: Powder mix for Mousse / Crème Dessert Product description: Neutral Powder mix for Mousse / Crème Dessert Techlogical information freeze- and thaw
More informationProduct Name and Number: 2710 Sunny Pop Popcorn Document #: Revision Date:10/15/2014 Revision #: 1 Revision Reason: New form Reviser: JS
Product Overview: Sunny Pop Popcorn is a great tasting popcorn that is made with three simple ingredients and meets or exceeds school nutritional guidelines. Product Physical Properties Flavor / Odor (sensory)
More informationProduct Information Sheet TASTEVA Stevia Sweetener
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationAs extraction is done by critical CO 2
DESCRIPTION HempFlax CBD Premix is a supercritical CO 2 extract from the leaves of industrial hemp varieties - listed on the EU variety list - mixed with cold pressed organic hemp seed oil. This product
More information# 2371 SOUR CREAM AND CHIVES SAVORY
Product Overview: Dry, free flowing powder produced with a uniform slightly tart cream and onion flavor. Maltodextrin based product able to maintain quality and consistency of color and flavor. Product
More informationProduct Specification
1. GENERAL INFORMATION Article number: Product demination: Eclair rmal pure butter Product description: Traditional choux pastry, texture soft after filling 2. SENSORY Taste: Odor: Colour: Texture: typical
More informationProduct Information Sheet SODA-LO EXTRA FINE
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More information232 ELEMENTAL IMPURITIES LIMITS
BRIEFING 232 Elemental Impurities Limits, USP 39 page 268. This chapter is being revised to address comments received and to further align this chapter with ICH Q3D. USP s Elemental Impurities Expert Panel
More information2008 No FOOD, ENGLAND. The Food Labelling (Declaration of Allergens) (England) Regulations 2008
STATUTORY INSTRUMENTS 2008 No. 1188 FOOD, ENGLAND The Food Labelling (Declaration of Allergens) (England) Regulations 2008 Made - - - - 24th April 2008 Laid before Parliament 1st May 2008 Coming into force
More informationProduct Specification
1. GENERAL INFORMATION Article number: Product demination: Instant powder mix for the production of fruit tart case with meringue character. Product description: powder mix for the production of fruit
More informationCBD CAPSULE (5MG) DESCRIPTION HempFlax s CBD capsule is made of a decarboxylated supercritical CO 2 GENERAL INFORMATION
DESCRIPTION HempFlax s CBD capsule is made of a decarboxylated supercritical CO 2 extract of industrial hemp leaves from varieties registered on the EU list, mixed with cold pressed organic hemp seed oil.
More informationProduct Specification
1. GENERAL INFORMATION Article number: Product denomination: Mini Loaf Cake Triple Chocolate and Chocolate Sauce, frozen Product description: Mini Loaf Cake Triple Chocolate Filled (96g), baked and frozen
More informationActual Excipient Test Data on Metal Impurities Submitted to IPEC-Americas from Industry
Actual Excipient Test Data on Metal Impurities Submitted to IPEC-Americas from Industry Priscilla Zawislak Chair Compendial Review Committee IPEC Americas Global Regulatory Affairs Manager Ashland Inc.
More informationGUARANTEE UNDER SECTION 303 (C) (2) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
GUARANTEE UNDER SECTION 303 (C) (2) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT FOR THE PURPOSE OF SECTION 303(C) (2) OF THE FEDERAL FOOD AND COSMETIC ACT, WE HEREBY GUARANTEE THAT, AS OF THE DATE OF EACH
More informationProduct specification
Product specification Blend 80% fat of which 68,5% butter fat and 31,5%veg veg. fat, salted Active Arla Foods / Basics Revised: 13/02/2013 Product specification no: 4414-00045 Version: 9 Dairy 4414 Authorization
More informationDeclaration for Enzymes for use in Oenological Practices
Declaration for Enzymes for use in Oenological Practices 25 March 2015 Food Fit for Human Consumption We hereby confirm that all raw materials used in the production of aforementioned products have a purity
More informationAllergies Policy including Nut & Food Allergy
140 Morley Hill Enfield EN2 0BG Gina s Montessori Nursery School Allergies Policy including Nut & Food Allergy Statement of Intent: This policy is concerned with a whole nursery approach to the health
More informationPRODUCT SPECIFICATION CHINESE 5 SPICE
PRODUCT SPECIFICATION CHINESE 5 SPICE 1) Physical Standards Product Code: Product Description: Ingredient Declaration: Country of Origin: Pack size: Appearance/Colour: Flavour and Odour: Particle Size:
More informationProduct Information Sheet RESISTAMYL
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationPRODUCT TECHNICAL DOSSIER SODIUM SELENITE ANHYDROUS
PRODUCT TECHNICAL DOSSIER SODIUM SELENITE ANHYDROUS Product Code: P19194 Raw Material Full Name: Sodium Selenite Anhydrous Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Sodium Selenite
More informationPRODUCT SPECIFICATION GARLIC WILD BEARS LEAF CUT
PRODUCT SPECIFICATION GARLIC WILD BEARS LEAF CUT 1) Physical Standards Product Code: CP264WBG Product Description: The dried, cleaned and cut leaves of Wild Bears Garlic which have not undergone fumigation,
More informationCOLLACTIVE HELPS MATURE SKIN BUILD LIFT AND FIRMING CUSHION 60% 50% Number of deep wrinkles (%) 40% 30% 28% 20% ANTI-WRINKLE EFFECT * 10% -10% -20%
Number of deep wrinkles (%) QUAL/FTE/122/h COLLACTIVE Marine Collagen & Elastin oligopeptides Skin anti-ageing & Hydration COLLACTIVE is composed of collagen and elastin oligopeptides in the same ratio
More informationPRODUCT SPECIFICATION CORIANDER SEED WHOLE INDORI STEAM TREATED
PRODUCT SPECIFICATION CORIANDER SEED WHOLE INDORI STEAM TREATED 1) Physical Standards Product Code: CP285CI Product Description: Whole Indori coriander seeds which have not undergone fumigation or irradiation
More information7475 West Main St. Milwaukee, WI 53214
Product Description A dough conditioner that helps in the machinability of the dough and improves the volume of the finished products. Regulatory Product is produced from materials that are wholesome and
More informationPRODUCT SPECIFICATION PIRI PIRI BLEND
PRODUCT SPECIFICATION PIRI PIRI BLEND 1) Physical Standards Product Code: Product Description: Ingredients: Country of Origin: Pack size: Appearance/Colour: Flavour and Odour: Particle Size: Metal Detection:
More informationPRODUCT SPECIFICATION GARAM MASALA HEAT TREATED
PRODUCT SPECIFICATION GARAM MASALA HEAT TREATED 1) Physical Standards Product Code: Product Description: Country of Origin: Pack size: Appearance/Colour: Flavour and Odour: Particle Size: CP118GM A standardised
More informationProduct Information Sheet MERIZET
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationQUALITATIVE COMPOSITION: INGREDIENTS: Potatoes, olive oil, sunflower oil, lyophilized raspberry and Raspberry flavouring. ORIGIN OF INGREDIENTS:
125 Grs RASPBERRY CHIPS TECHNICAL DATA SHEET POTATO CHIPS According to Royal Decree 126/1989 defines fried potatoes as product obtained from healthy potatoes, without signs of soiling, peeled, properly
More informationEAN REFERENCE PRODUCT NET WEIGHT EXTRA VIRGIN OLIVE OIL & HIMALAYAN PINK SALT CHIPS QUALITATIVE COMPOSITION:
2x200 Grs EXTRA VIRGIN OIL & HIMALAYAN PINK SALT CHIPS TECHNICAL DATA SHEET GOURMET POTATO CHIPS According to Royal Decree 126/1989 defines fried potatoes as product obtained from healthy potatoes, without
More informationMulti Analyte Custom Grade Solution
1.0 ACCREDITATION / REGISTRATION INORGANIC VENTURES is accredited to ISO Guide 34, "General Requirements for the Competence of Reference Material Producers" and ISO/IEC 17025, "General Requirements for
More informationInformation to Consumers Regulation (EU) Nº 1169/2011. Ana Oliveira
Information to Consumers Regulation (EU) Nº 1169/2011 Ana Oliveira ana.oliveira@frulact.com 23-05-2017 Legal Framework Regulation (EU) nº 1169/2011 Directive 2000/13/EC Labelling, presentation and advertising
More informationProduct Specification
1. GENERAL INFORMATION Article number: Product demination: Muffin Triple Chocolate, frozen Product description: Muffin Triple Chocolate (123g), baked and frozen 2. SENSORY Taste: Odor: Colour: chocolate,
More informationCountry Range Tricolour Spirals
Supplier's Product Code : GAR009 Product Added : 12 September 2017 Last Updated by Supplier : 12 September 2017 erudus id : 23f079ae278b49a59f38e29d08ea44d7 The information on the Erudus System has been
More informationFlour Specification. Name: Allied Mills AM James Neill. AM Central Office Port of Tilbury Tilbury Essex RM18 7JR
LIMS Date of Issue: 19th March 2009 LIMS: Revision No: 8 Supplied as: Bulk Bag Name & Address: Flour Specification Supplier Manufacturing site Name: Allied Mills AM James Neill Address: AM Central Office
More informationPRODUCT SPECIFICATION ORGANIC GROUND BLACK PEPPER 60#
PRODUCT SPECIFICATION ORGANIC GROUND BLACK PEPPER 60# 1) Physical Standards Product Code: Product Description: Botanical Name: Country of Origin: Pack size: Particle Size: Appearance/Colour: Flavour and
More informationProduct Information Sheet MALTOSWEET
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationFilms Business PRODUCT SAFETY BULLETIN Metallyte MET-HB2
U.S. Regulatory Information Food Contact Status (FDA) This product for food packaging applications is produced with olefin polymers which have been certified by our suppliers to be in compliance with the
More informationCERTIFICATE OF ANALYSIS. tel: fax:
CERTIFICATE OF ANALYSIS 300 Technology Drive Christiansburg, VA 24073. USA inorganicventures.com tel: 800.669.6799. 540.585.3030 fax: 540.585.3012 info@inorganicventures.com 1.0 ACCREDITATION / REGISTRATION
More informationFood Allergen Environmental Monitoring Guide
Food Allergen Environmental Monitoring Guide A EUROFINS WHITE PAPER OCTOBER 2012 This document by Eurofins is licensed under a Creative Commons Attribution 3.0 Unported License. A COMPREHENSIVE GUIDE TO
More informationFilms Business PRODUCT STEWARDSHIP FACT SHEET Bicor AB-X
U.S. Regulatory Information Food Contact Status (FDA) This product for food packaging applications is produced with olefin polymers which have been certified by our suppliers to be in compliance with the
More information