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Scientific Documentation Scientific Documentation A1378, Aspartame, Powder, NF 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 Ver4.05 27.July.2020 A1378, Aspartame, Powder, NF 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 EU Fragrance 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 Specification for Aspartame, Powder, NF (A1378) Item Number A1378 Item Aspartame, Powder, NF CAS Number 22839-47-0 Molecular Formula C14H18N2O5 Molecular Weight 294.31 MDL Number Synonyms APM ; N-L-alpha-Aspartyl-L-phenylalanine 1-Methyl Ester Test Specification Min Max ASSAY (DRIED BASIS) 98.0 102.0 % TRANSMITTANCE @430 nm 0.95 SPECIFIC ROTATION [a]D +14.5 to +16.5° LOSS ON DRYING 4.5 % RESIDUE ON IGNITION 0.2 % ELEMENTAL IMPURITIES: LEAD AS REPORTED CADMIUM (Cd) AS REPORTED ARSENIC (As) AS REPORTED MERCURY (Hg) AS REPORTED 5-BENZY-3,6-DIOXO-2-PIPERAZINEACETIC ACID 1.5 % CHROMATOGRAPHIC PURITY 2.0 % SPECTRUM MATCHES IDENTIFICATION REFERENCE CERTIFIED HALAL APPEARANCE EXPIRATION DATE DATE OF MANUFACTURE RESIDUAL SOLVENTS AS REPORTED Certificate Of Analysis Item Number A1378 Lot Number 2IJ0036 Item Aspartame, Powder, NF CAS Number 22839-47-0 Molecular Formula C14H18N2O5 Molecular Weight 294.31 Test Specification Result min max ASSAY (DRIED BASIS) 98.0 102.0 % 98.3 % TRANSMITTANCE @430 nm 0.95 0.99 SPECIFIC ROTATION [a]D +14.5 to+16.5° +15.6° LOSS ON DRYING 4.5 % 3.6 % RESIDUE ON IGNITION 0.2 % 0.1 % ELEMENTAL IMPURITIES: . LEAD AS REPORTED NONE DETECTED CADMIUM (Cd) AS REPORTED NONE DETECTED ARSENIC (As) AS REPORTED NONE DETECTED MERCURY (Hg) AS REPORTED NONE DETECTED 5-BENZY-3,6-DIOXO-2-PIPERAZINEACETIC ACID 1.5 % <0.1 % CHROMATOGRAPHIC IMPURITIES 2.0 % 0.0 % SPECTRUM SPECTRUM IDENTIFICATION MATCHES MATCHES REFERENCE REFERENCE EXPIRATION DATE 06-FEB-2022 DATE OF MANUFACTURE 06-FEB-2019 APPEARANCE WHITE POWDER RESIDUAL SOLVENTS AS REPORTED . CLASS 1 (solvent) / BENZENE <2 ppm CLASS 2 (SOLVENT) / METHANOL <3000 ppm 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: 7/27/2015 Revision date 5/7/2019 Revision Number: G3 1. IDENTIFICATION Product identifier Product code: A1378 Product Name: ASPARTAME, POWDER, NF Other means of identification Synonyms: Succinamic acid, 3-amino-N-(alpha-carboxyphenethyl)-, N-methyl ester, stereoisomer 3-Amino-N-(alpha-carboxyphenethyl) succinamic acid N-methyl ester, stereoisomer Aspartylphenylalanine methyl ester N-L-alpha Aspartyl-L-phenlalanine 1-methyl ester Nutrasweet L-Phenylalanine, N-L-alpha-aspartyl, 1-methyl ester Equal Methyl aspartylphenylalanate 1-Methyl N-L-alpha-aspartyl-L-phenylalanine CAS #: 22839-47-0 RTECS # WM3407000 CI#: Not available Recommended use of the chemical and restrictions on use Recommended use: Sweetener. Laboratory chemicals. Research and Development. Uses advised against No information available Supplier: Spectrum Chemical Mfg. Corp 14422 South San Pedro St. Gardena, CA 90248 (310) 516-8000 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 not 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) Label elements Not classified Product code: A1378 Product name: ASPARTAME, Page 1 / 11 POWDER, NF Hazards not otherwise classified (HNOC) Not Applicable Other hazards Not available 3. COMPOSITION/INFORMATION ON INGREDIENTS Component CAS No Weight-% Aspartame 22839-47-0 100 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. Consult a physician if necessary. 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 not breathing, give artificial respiration. If breathing is difficult, give oxygen. 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 gastrointestinal disturbances May cause digestive (gastrointestinal) tract irritation Abdominal pain May cause nausea and headache May cause diarrhea It may affect the brain Central nervous system effects Central nervous system depression May cause drowsiness or dizziness Headache Confusion Anxiety Irritability Insomnia May affect behavior/central nervous system (convulsions, tremors, aggression) Slurred speech May cause personality and mood changes May affect the cardiovascular system May affect the liver It may affect the kidneys May cause tinnitus Hearing impairment Product code: A1378 Product name: ASPARTAME, Page 2 / 11 POWDER, NF May affect eyes/vision Paresthesia (numbness and tingling of the extremities) May cause hyperactivity and restless legs Indication of any immediate medical attention and special treatment needed Notes to Physician: Treat symptomatically. Protection of first-aiders 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: Dry chemical. Carbon dioxide (CO2). Water spray mist, or foam. Unsuitable Extinguishing Media: No information available. Specific hazards arising from the chemical Hazardous combustion products Carbon Monoxide, Carbon Dioxide. Nitrogen oxides (NOx). Specific hazards May be combustible at high temperatures. Fire may produce irritating and/or toxic gases. 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 emergency procedures Personal Precautions: Ensure adequate ventilation. Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Remove all sources of ignition. Environmental precautions Prevent further leakage or spillage. Prevent product from entering drains. Methods and material for containment and cleaning up Methods for containment Stop leak if you can do it without risk. Cover with plastic sheet to prevent spreading. Methods for cleaning up Sweep up and shovel into suitable containers for disposal. Clean contaminated surface thoroughly. 7. HANDLING AND STORAGE Precautions for safe handling Technical Measures/Precautions: Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation. All equipment used when Product code: A1378 Product name: ASPARTAME, Page 3 / 11 POWDER, NF handling the product must be grounded. Keep away from incompatible materials. Safe Handling Advice Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Do not ingest. Do not breathe dust. Keep away from heat and sources of ignition. Handle in accordance with good industrial hygiene and safety practice. Conditions
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