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DE140, Dextrose, Anhydrous, USP, EP, BP, JP Scientific Documentation DE140, Dextrose, Anhydrous, USP, EP, BP, JP Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package. Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300 Ver4.06 26.February.2021 DE140, Dextrose, Anhydrous, USP, EP, BP, JP Table of Contents Product Specification Certificate of Analysis Sample(s) Safety Data Sheet (SDS) Certification of Current Good Manufacturing Practices (cGMP) Manufacturing Process Flowchart Source Statement BSE/TSE Statement Allergen Statement GMO Statement Melamine Statement Nitrosamine Statement Animal Testing Statement Organic Compliance Statement Shelf Life Statement Other Chemicals Statement Elemental Impurities Statement Residual Solvents Statement General Label Information – Sample Label General Lot Numbering System Guidance Kosher Certificate Halal Certificate Specification for Dextrose, Anhydrous, USP, EP, BP, JP (DE140) Item Number DE140 Item Dextrose, Anhydrous, USP, EP, BP, JP CAS Number 50-99-7 Molecular Formula C6H12O6 Molecular Weight 180.20 MDL Number Synonyms Corn Sugar ; Glucose ; D-Glucose Test Specification Min Max ASSAY (JP) 99.5% 101.0 % ASSAY (ANHYDROUS BASIS; EP, USP) 97.5 102.0 % ACIDITY RED COLOR DEVELOPS LOSS ON DRYING (JP) 1.0 % WATER (EP) 1.0 % CLEAR / NO MORE COLOR COLOR AND CLARITY OF SOLUTION THAN STANDARD RESIDUE ON IGNITION (JP) 0.1 % CONDUCTIVITY 20 µS/cm CHLORIDE (Cl) 0.018 % SULFATE (SO4) 0.024 % ARSENIC (As) 1.3 ppm ELEMENTAL IMPURITIES AS REPORTED HEAVY METALS (JP) 4 ppm SAMPLE DISOLVES DEXTRIN COMPLETELY SOLUBLE STARCH, SULFITES (EP) 15 ppm SOLUBLE STARCH AND SULFITES (USP, JP) SOLUTION IS YELLOW RELATED SUBSTANCES: MALTOSE AND ISOMALTOSE (IMPURITY A & B ) 0.4 % MALTOTRIOSE ( IMPURITY C ) 0.2 % FRUCTOSE ( IMPURITY D ) 0.15 % UNSPECIFIED IMPURITIES 0.10 % TOTAL IMPURITIES 0.5 % SPECTRUM MATCHES IDENTIFICATION (A) USP REFERENCE IDENTIFICATION (B) USP RETN TM MATCH ST IDENTIFICATION (C) USP 1.0 % IDENTIFICATION (A) EP +52.5 to +53.3° CHROMATOGRAM IDENTIFICATION (C) EP MATCHES STANDARD IDENTIFICATION (D) EP RED PRECIPITATE APPEARANCE CERTIFIED KOSHER CERTIFIED HALAL EXPIRATION DATE DATE OF MANUFACTURE RESIDUAL SOLVENTS AS REPORTED MONOGRAPH EDITION MONOGRAPH EDITION. MONOGRAPH EDITION.. Certificate Of Analysis Item Number DE140 Lot Number 2KA0307 Item Dextrose, Anhydrous, USP, EP, BP, JP CAS Number 50-99-7 Molecular Formula C6H12O6 Molecular Weight 180.20 Test Specification Result min max ASSAY (JP) 99.5% 101.0 % 100.4% ASSAY (ANHYDROUS BASIS; EP, USP) 97.5 102.0 % 100.4% ACIDITY RED COLOR RED COLOR DEVELOPS DEVELOPS LOSS ON DRYING (JP) 1.0 % 0.3% WATER (EP) 1.0 % 0.03% CLEAR / NO MORE CLEAR/NO MORE COLOR AND CLARITY OF SOLUTION COLOR THAN COLOR THAN STANDARD STANDARD RESIDUE ON IGNITION (JP) 0.1 % 0.01% CONDUCTIVITY 20 µS/cm 0.8 µS/cm CHLORIDE (Cl) 0.018 % <0.018% SULFATE (SO4) 0.024 % <0.024% ARSENIC (As) 1.3 ppm <0.01 ppm ELEMENTAL IMPURITIES COMPLIES TO AS REPORTED STANDARD HEAVY METALS (JP) 4 ppm <4 ppm SAMPLE DEXTRIN SAMPLE DISOLVES DISSOLVES COMPLETELY COMPLETELY SOLUBLE STARCH, SULFITES (EP) 15 ppm <15 ppm SOLUBLE STARCH AND SULFITES (USP, JP) SOLUTION IS SOLUTION IS YELLOW YELLOW RELATED SUBSTANCES: . MALTOSE AND ISOMALTOSE (IMPURITY A & B ) 0.4 % 0.1% MALTOTRIOSE ( IMPURITY C ) 0.2 % 0.0 % FRUCTOSE ( IMPURITY D ) 0.15 % 0.00 % UNSPECIFIED IMPURITIES 0.10 % 0.01 % TOTAL IMPURITIES 0.5 % 0.1 % SPECTRUM SPECTRUM IDENTIFICATION (A) USP MATCHES MATCHES REFERENCE REFERENCE RETENTION TIME IDENTIFICATION (B) USP RETN TM MATCH MATCHES ST STANDARD IDENTIFICATION (C) USP 1.0 % 0.03% IDENTIFICATION (A) EP +52.5 to +53.3° +52.6° CHROMATOGRAM CHROMATOGRAM IDENTIFICATION (C) EP MATCHES MATCHES STANDARD STANDARD IDENTIFICATION (D) EP RED PRECIPITATE RED PRECIPITATE FORMS APPEARANCE WHITE GRANULAR POWDER CERTIFIED KOSHER CERTIFIED KOSHER CERTIFIED HALAL CERTIFIED HALAL EXPIRATION DATE 26-DEC-2023 DATE OF MANUFACTURE 26-DEC-2020 RESIDUAL SOLVENTS NO RESIDUAL AS REPORTED SOLVENT USED MONOGRAPH EDITION (USP) 43 MONOGRAPH EDITION. (EP) 10 MONOGRAPH EDITION.. (JP) 17 Spectrum Chemical Mfg Corp 755 Jersey Avenue New Brunswick 08901 NJ All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia. Read and understand label and SDS before handling any chemicals. All Spectrum's chemicals are for manufacturing, processing, repacking or research purposes by experienced personnel only. It is the customer's responsibility to provide adequate hazardous material training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical. The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understanding of the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials or manufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes. Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018. More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient daily exposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products. SAFETY DATA SHEET Preparation Date: 8/13/2014 Revision date 6/6/2018 Revision Number: G3 1. IDENTIFICATION Product identifier Product code: DE140 Product Name: DEXTROSE, ANHYDROUS, GRANULAR, USP, EP, BP, JP Other means of identification Synonyms: Cartose Cerelose Corn sugar D-Glucose, anhydrous Dextropur Dextrose Dextrosol Glucolin Glucose Glucose, anhydrous CAS #: 50-99-7 RTECS # LZ6600000 CI#: Not available Recommended use of the chemical and restrictions on use Recommended use: In Foods. Uses advised against No information available Supplier: Spectrum Chemical Mfg. Corp 14422 South San Pedro St. Gardena, CA 90248 (310) 516-8000 Distributed by: TekniScience 2425 Édouard Michelin Blvd. Terrebonne, Qc Canada J6Y 4P2 Telephone: 1-800-267-9799 Order Online At: https://www.spectrumchemical.com Emergency telephone number Chemtrec 1-800-424-9300 Contact Person: Tom Tyner (USA - West Coast) Contact Person: Ibad Tirmiz (USA - East Coast) 2. HAZARDS IDENTIFICATION Classification This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Not a dangerous substance or mixture according to the Globally Harmonized System (GHS) Product code: DE140 Product name: DEXTROSE, Page 1 / 12 ANHYDROUS, GRANULAR, USP, EP, BP, JP Combustible dust - Label elements Warning May form combustible dust concentrations in air Hazards not otherwise classified (HNOC) Not Applicable Other hazards Not available Precautionary Statements - Prevention Prevent dust accumulations to minimize explosion hazard Keep away from all ignition sources including heat, sparks, and flame Keep container closed and grounded 3. COMPOSITION/INFORMATION ON INGREDIENTS Component CAS No Weight-% Glucose (Dextrose), Anhydrous 50-99-7 100 4. FIRST AID MEASURES First aid measures General Advice: National Capital Poison Center in the United States can provide assistance if you have a poison emergency and need to talk to a poison specialist. Call 1-800-222-1222. Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing and shoes. Get medical attention if irritation develops. Eye Contact: Flush eyes with water for 15 minutes. Get medical attention if irritation occurs. If symptoms persist, call a physician. Inhalation: Move to fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration. Get medical attention. Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person. Consult a physician if necessary. Most important symptoms and effects, both acute and delayed Symptoms May cause eye/skin irritation May cause gastrointestinal disturbances May cause hypermotility, diarrhea Indication of any immediate medical attention and special treatment needed Notes to Physician: Treat symptomatically. Protection of first-aiders Product code: DE140 Product name: DEXTROSE, Page 2 / 12 ANHYDROUS, GRANULAR, USP, EP, BP, JP First-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose of contaminated clothing and equipment as bio-hazardous waste. 5. FIRE-FIGHTING MEASURES Extinguishing Media Suitable Extinguishing Media: Carbon dioxide (CO2). Dry chemical. Water spray mist or foam. Unsuitable Extinguishing Media: No information available. Specific hazards arising from the chemical Hazardous combustion products Carbon Monoxide, Carbon Dioxide. Specific hazards May be combustible at high temperatures. Avoid generating dust. Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust explosion hazard. Special Protective Actions for Firefighters Specific Methods: No information available Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear 6. ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and
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