Scientific Documentation ET107, Dehydrated Alcohol, 200 Proof, Undenatured, USP 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 16.October.2020 ET107, Dehydrated Alcohol, 200 Proof, Undenatured, USP 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 Kosher Certificate Specification for Dehydrated Alcohol, 200 Proof, Undenatured, USP (ET107) Item Number ET107 Item Dehydrated Alcohol, 200 Proof, Undenatured, USP CAS Number 64-17-5 Molecular Formula C2H5OH Molecular Weight 46.07 MDL Number Synonyms Absolute Ethyl Alcohol ; Anhydrous Ethanol ; Ethanol ; Grain Derived Alcohol Test Specification Min Max ASSAY (by VOLUME) 99.5 % NOT MORE OPALESENT CLARITY OF SOLUTION THAN STANDARD NOT MORE INTENSE THAN COLOR OF SOLUTION STANDARD ACIDITY OR ALKALINITY SOLUTION IS PINK SPECIFIC GRAVITY @ 15.56oC 0.7962 UV ABSORPTION: 240 nm 0.40 250 - 260 nm 0.30 270 - 340 nm 0.10 ORGANIC IMPURITIES: METHANOL 200 μL/L ACETALDEHYDE AND ACETAL 10 μL/L BENZENE 2 μL/L SUM OF ALL OTHER IMPURITIES 300 μL/L LIMIT OF NONVOLATILE RESIDUE 2.5 mg ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION A 0.7962 SPECTRUM MATCHES IDENTIFICATION B REFERENCE IDENTIFICATION (C) LIMIT OF METHANOL 200 μL/L CERTIFIED KOSHER APPEARANCE EXPIRATION DATE DATE OF MANUFACTURE RESIDUAL SOLVENTS AS REPORTED CLASS 3 (solvent) / 1-PROPANOL . CLASS 3 (solvent) / 2-PROPANOL . MONOGRAPH EDITION Certificate Of Analysis Item Number ET107 Lot Number 2JG0107 Item Dehydrated Alcohol, 200 Proof, Undenatured, USP CAS Number 64-17-5 Molecular Formula C2H5OH Molecular Weight 46.07 Test Specification Result min max &88&> G^;41:2* 99.5 % 99.98 % NOT MORE NOT MORE (1&7.9>4+841:9.43 OPALESENT THAN OPALESENT THAN STANDARD STANDARD NOT MORE NOT MORE (41474+841:9.43 INTENSE THAN INTENSE THAN STANDARD STANDARD &(.).9>47&10&1.3.9> SOLUTION IS PINK SOLUTION IS PINK 85*(.+.(,7&;.9>%o( 0.7962 0.7937 :;&'84759.43 . SR 0.40 0.2482 SR 0.30 0.0976 SR 0.10 0.0111 47,&3.(.25:7.9.*8 . 2*9-&341 200 μL/L < 200 μL/L &(*9&1)*->)*&3)&(*9&1 10 μL/L < 10 μL/L '*3?*3* 2 μL/L < 2 μL/L 8:24+&1149-*7.25:7.9.*8 300 μL/L < 300 μL/L 1.2.94+343;41&9.1*7*8.):* 2.5 mg 0.0 mg NO ELEMENTAL *1*2*39&1.25:7.9.*8 AS REPORTED IMPURITIES PRESENT .)*39.+.(&9.43& 0.7962 0.7937 SPECTRUM SPECTRUM .)*39.+.(&9.43' MATCHES MATCHES REFERENCE REFERENCE (*79.+.*)048-*7 CERTIFIED KOSHER &55*&7&3(* CLEAR LIQUID *=5.7&9.43)&9* 07-JUL-2023 )&9*4+2&3:+&(9:7* 07-JUL-2020 7*8.):&1841;*398 AS REPORTED . (1&88 XTQ[JSY5745&341 . <300 ppm (1&88 XTQ[JSY5745&341 . <300 ppm 2434,7&5-*).9.43 USP 42 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: 9/27/2013 Revision date 8/26/2019 Revision Number: G10 1. IDENTIFICATION Product identifier Product code: ET107 Product Name: DEHYDRATED ALCOHOL, 200 PROOF, USP Other means of identification Synonyms: Absolute ethanol Alcohol Alcohol dehydrated Alcohol, anhydrous Alcool ethylique (French) Absolute Ethanol 200 proof Ethanol Ethyl alcohol anhydrous Ethyl hydrate Ethyl hydroxide Fermentation alcohol Dehydrated Alcohol Ethanol, undenatured 200 proof Ethanol 200 proof Ethyl alcohol Alcohol etílico (Spanish) CAS #: 64-17-5 RTECS # KQ6300000 CI#: Not available Recommended use of the chemical and restrictions on use Recommended use: Solvent. Perfuming agent. In pharmaceuticals. Inks. In organic synthesis. In beverages. 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 considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS) Product code: ET107 Product name: DEHYDRATED Page 1 / 14 ALCOHOL, 200 PROOF, USP Serious eye damage/eye irritation Category 2 Reproductive toxicity Category 1A Specific target organ toxicity (single exposure) Category 3 Specific target organ toxicity (repeated exposure) Category 1 Flammable liquids Category 2 Label elements Danger Hazard statements Causes serious eye irritation May damage fertility or the unborn child May cause respiratory irritation. May cause drowsiness or dizziness Causes damage to organs through prolonged or repeated exposure Highly flammable liquid and vapor Hazards not otherwise classified (HNOC) Not Applicable Other hazards Can burn with an invisible flame Causes mild skin irritation Precautionary Statements - Prevention Obtain special instructions before use Do not handle until all safety precautions have been read and understood Wash face, hands and any exposed skin thoroughly after handling Do not breathe mist or vapors Do not eat, drink or smoke when using this product Wear protective gloves/protective clothing/eye protection/face protection Use only outdoors or in a well-ventilated area .HHSDZD\IURPKHDWVSDUNVRSHQIODPHVKRWVXUIDFHV²1RVPRNLQJ Keep container tightly closed Ground container and receiving equipment Use explosion-proof equipment Use only non-sparking tools Take precautionary measures against static discharge Keep cool Precautionary Statements - Response IF exposed or concerned: Get medical attention In case of fire: Use CO2, dry chemical, or foam to extinguish. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention. If skin irritation occurs: Get medical attention IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or physician if you feel unwell. Precautionary Statements - Storage Store locked up Store in a well-ventilated place. Keep container tightly closed Product code: ET107 Product name: DEHYDRATED Page 2 / 14 ALCOHOL, 200 PROOF, USP Precautionary Statements - Disposal Dispose of contents and container to an approved waste disposal plant in accordance with local, regional, national and international regulations as applicable 3. COMPOSITION/INFORMATION ON INGREDIENTS Component CAS No Weight-% Ethyl Alcohol 200 proof 64-17-5 100 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 skin irritation persists, call a physician. Eye Contact: Flush eyes with water for 15 minutes. Get medical attention. 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 Causes eye irritation May cause skin irritation May cause irritation of respiratory tract Dyspnea (Difficulty breathing and shortness of breath) Central nervous system effects Dizziness Drowsiness Headache Ataxia Staggering gait Nausea Vomiting May cause cardiovascular effects Indication of any immediate medical attention and special treatment needed Notes to Physician: Treat symptomatically.