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Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone  732.214.1300   

Ver4.04  25.July.2019 

    Scientific Documentation D1258, Dimethyl Sulfoxide, USP

Dear Customer,

Thank you for your interest in Spectrum’s quality products and services.

Spectrum has been proudly serving the scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time.

To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers.

At Spectrum, Quality is priority number one. Suppliers with the best qualifications are preferred and we employ full-functioning in-house analytical laboratories at each of our facilities. Our facilities and systems are USFDA registered and ISO certified. We frequently host customer audits and cherish opportunities for improvements. Quality is engrained into our culture. Quality is priority number one.

In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas.

We appreciate your business and we look forward to hearing from you.

Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance mdang@spectrumchemical.com

25.July.2019

D1258, Dimethyl Sulfoxide, USP

Table of Contents

Product Specification

Safety Data Sheet (SDS)

Manufacturing Process Flowchart

Certification of Quality Management System (QMS)

Certification of current Good Manufacturing Practices (cGMP)

Product BSE/TSE Statement

Product Allergen Statement

Product Aflatoxin Statement

Product Certificate of Analysis Sample(s)

General Label Information – Sample Label

General Lot Numbering System Guidance

Stability – Shelf Life Guidance

Halal Certificate

Specification for Dimethyl Sulfoxide, USP (D1258)

Item Number D1258

Item Dimethyl Sulfoxide, USP

CAS Number 67-68-5

Molecular Formula C2H6OS

Molecular Weight 78.13

MDL Number

Synonyms DMSO ; Methyl Sulfoxide

Test SpecificationMin Max

ASSAY (ANHYDROUS BASIS) 99.9%

SPECIFIC GRAVITY 1.095 1.101

REFRACTIVE INDEX 1.4755 1.4775

NONVOLATILE RESIDUE 0.01 %

RELATED COMPOUNDS (TOTAL IMPURITIES) 0.1 %

WATER DETERMINATION 0.1 %

ACIDITY TO PASS TEST

ULTRAVIOLET ABSORBANCE TO PASS TEST

ELEMENTAL IMPURITIES AS REPORTED

IDENTIFICATION TO PASS TEST

CERTIFIED HALAL

RETEST DATE

DATE OF MANUFACTURE

APPEARANCE

RESIDUAL SOLVENTS TO PASS TEST

SAFETY DATA SHEETPreparation Date: 9/15/2014 Revision Date: 9/13/2018 Revision Number: G4

1. IDENTIFICATIONProduct identifier

Product code: D1258Product Name: DIMETHYL SULFOXIDE, USP

Other means of identification Synonyms: Dimethyl sulphoxide

DMSOMethane, sulfinylbis-MethylsulfinylmethaneMethyl SulfoxideSulfinylbis(methane)Diméthylsulfoxyde (French)Sulfoxyde diméthylique (French)Dimetil sulfóxido (Spanish)

CAS #: 67-68-5RTECS # PV6210000CI#: Not available

Recommended use of the chemical and restrictions on use Recommended use: Solvent. Paint remover. In industrial cleaners. In organic reactions. Analytical

reagent.Uses advised against No information available

Supplier: Spectrum Chemical Mfg. Corp14422 South San Pedro St.Gardena, CA 90248(310) 516-8000

Order Online At: https://www.spectrumchemical.com Emergency telephone number Chemtrec 1-800-424-9300Contact Person: Martin LaBenz (West Coast)Contact Person: Ibad Tirmiz (East Coast)

2. HAZARDS IDENTIFICATION

Classification

This chemical is considered hazardous according to the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS)

Serious eye damage/eye irritation Category 2B

Label elements

Flammable liquids Category 4

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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Hazards not otherwise classified (HNOC) Not Applicable

Other hazards Not available

Precautionary Statements - PreventionWash face, hands and any exposed skin thoroughly after handlingKeep away from heat/sparks/open flames/hot surfaces. — No smokingWear protective glovesWear eye/face protection

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. Ifeye irritation persists: Get medical advice/attention.

Precautionary Statements - StorageStore in a well-ventilated place. Keep cool

Precautionary Statements - DisposalDispose of contents/container to an approved waste disposal plant

3. COMPOSITION/INFORMATION ON INGREDIENTS

Components CAS-No. Weight %Dimethyl Sulfoxide 67-68-5 100

4. FIRST AID MEASURES

First aid measures

General Advice: National Capital Poison Center in the United States can provide assistance if youhave a poison emergency and need to talk to a poison specialist. Call1-800-222-1222.

Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing andshoes. Get medical attention.

Eye Contact: Flush eyes with water for 15 minutes. Get medical attention.

Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, giveoxygen. Get medical attention.

Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Obtain medical attention.

Most important symptoms and effects, both acute and delayed

Symptoms Ingestion may cause gastrointestinal irritation, nausea, vomiting, and diarrheaMay cause constipationMay cause anorexiaCentral nervous system effectsMay cause headache

Warning

Hazard statementsCauses eye irritationCombustible liquid

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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DizzinessAtaxiaMay affect behavior/central nervous system (tremor, convulsions)AnalgesiaMay cause cardiovascular effectsIt may cause transient photophobia and disturbances of visionMay affect respirationMay cause cyanosisMay affect the liverIt may affect the kidneysMay cause hypoglycemia

Indication of any immediate medical attention and special treatment needed

Notes to Physician: Treat symptomatically.

Protection of first-aidersFirst-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose ofcontaminated 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: High volume water jet. Do not use a solid (straight) waterstream as it may scatter and spread fire.

Specific hazards arising from the chemical

Hazardous Combustion Products: Carbon Monoxide, Carbon Dioxide. Sulfur Oxides.Formaldehyde. Methyl mercaptan.

Specific hazards: Combustible material. May be ignited by heat, sparks orflames. Container explosion may occur under fireconditions or when heated. Vapors may form explosivemixtures with air. Most vapors are heavier than air. Theywill spread along the ground and collect in low or confinedareas (sewers, basements, tanks). Fire may produceirritating, corrosive and/or toxic gases.

Special Protective Actions for Firefighters

Specific Methods: Water mist may be used to cool closed containers. Forlarger fires, use water spray or fog. Cool containers withflooding quantities of water until well after fire is out.

Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatuspressure-demand, MSHA/NIOSH (approved or equivalent)and full protective gear

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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7. HANDLING AND STORAGE

Precautions for safe handling

Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Remove all sources of ignition. To avoid ignition ofvapors by static electricity discharge, all metal parts of the equipment must be grounded. Keep away fromincompatible materials.

Safe Handling AdviceWear personal protective equipment. Avoid contact with skin, eyes and clothing. Keep away from heat andsources of ignition. Take precautionary measures against static discharges. Do not ingest. Do not breathe vaporsor spray mist. Handle in accordance with good industrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities

Technical Measures/Storage Conditions:Hygroscopic. Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in theoriginal container. Keep away from heat and sources of ignition. Store in a segregated and approved area. Storeaway from incompatible materials.

Incompatible Materials:Oxidizing agentsAcidsBasesAlkali MetalsAcid chloridesAcid anhydridesPotassium t-butoxideboron compoundsSodium isopropoxideDinitrogen tetraoxideCarbonyl diisothiocyanateAcetanilideMany acyl, aryl, and nonmetal halides (eg acetyl chloride, benzenesulfonyl chloride, bromobenzoyl actanilide,cyanuric chloride, iodine pentafluoride, Mg(ClO4)2, CH3Br, NiO4, oxalyl chloride, P2O3, phosphorus trichloride,

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Personal Precautions: Ensure adequate ventilation. Keep people away from and upwind of spill/leak. Avoidcontact with skin, eyes and clothing. Do not touch damaged containers or spilled materialunless wearing appropriate protective clothing. Use personal protective equipment.Remove all sources of ignition. Use spark-proof tools and explosion-proof equipment. Allequipment used when handling the product must be grounded.

Environmental precautions Prevent further leakage or spillage if safe to do so. Do not let product enter drains.Prevent entry into waterways, sewers, basements or confined areas.

Methods and material for containment and cleaning up

Methods for containment Stop leak if you can do it without risk. Absorb spill with inert material (e.g.vermiculite, dry sand or earth). In case of large spill, dike if needed. Dike farahead of liquid spill for later disposal.

Methods for cleaning up Use appropriate tools to put the spilled material in a suitable chemical wastedisposal container. Use clean non-sparking tools to collect absorbed material.Clean contaminated surface thoroughly.

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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phosphoryl chloride, silver fluoride, silver difluoride, sodium hydride, sulfur dichloride, disulfur dichloride,sulfurylchloride, tetrachlorosilane, and thionyl chloride)

8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters

National occupational exposure limits

United States

Components CAS-No. OSHA NIOSH ACGIH AIHA WEELDimethyl Sulfoxide 67-68-5 None None None 250 ppm TWA

Canada

Components CAS-No. Canada - Alberta Canada - BritishColumbia

Canada - Ontario Canada - Quebec

Dimethyl Sulfoxide 67-68-5 None None None None

Australia and Mexico

Components CAS-No. Australia MexicoDimethyl Sulfoxide 67-68-5 None None

Appropriate engineering controls

Engineering measures to reduce exposure: Ensure adequate ventilation. Provide exhaust ventilation orother engineering controls to keep the airborneconcentrations of vapors and mist below their respectivethreshold limit value.

Individual protection measures, such as personal protective equipment

Personal Protective Equipment

Eye protection: Goggles

Skin and body protection: Long sleeved clothingChemical resistant apronGloves

Respiratory protection: Vapor respirator. Be sure to use an approved/certified respirator or equivalent.Respiratory protection is not necessary for normal handling. Good roomventilation or use of local exhaust (fume hood) is sufficient. Use a vapor respiratorunder conditions where exposure to the substance is apparent (e.g. generation ofhigh concentrations of mist or vapor, inadequate ventilation, development ofrespiratory tract irritation), and engineering controls are not feasible. Be sure touse an approved/certified respirator or equivalent.

Hygiene measures: Avoid contact with skin, eyes and clothing. Wash hands before breaks andimmediately after handling the product. When using, do not eat, drink or smoke.

9. PHYSICAL AND CHEMICAL PROPERTIES

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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10. STABILITY AND REACTIVITYReactivity No information available

Chemical stability

Stability: Stable under recommended storage conditions.

Possibility of Hazardous Reactions: Hazardous polymerization does not occur

Conditions to avoid: Heat. Ignition sources. Exposure to moisture. Exposure to moist air. Incompatiblematerials.

Incompatible Materials: Oxidizing agentsAcidsBasesAlkali MetalsAcid chloridesAcid anhydridesPotassium t-butoxideboron compoundsSodium isopropoxide

Physical state:Liquid

Appearance:No information available.

Color:Clear. Colorless.

Odor:Slight. Sulfurous. Distinctive garlic oroyster-like.

TasteSlightly bitter with a sweet after-taste.

Formula:C2-H6-O-S

Molecular/Formula weight (g/mole):78.13

Flammability:No information available

Flash point (°C):89

Flashpoint (°C/°F):89 °C/192.2 °F95 °C/203 °F

Flash Point Tested according to:Closed cupOpen cup

Autoignition Temperature (°C/°F):215 °C/419 °F

Lower Explosion Limit (%):2.6%

Upper Explosion Limit (%):42%

Melting point/range(°C/°F):18.45 °C/65.2 °F

Decomposition temperature(°C/°F):No information available

Boiling point/range(°C/°F):189 °C/372.2 °F

Bulk density:No information available

Density (g/cm3):No information available

Specific gravity:1.100

pH:No information available

Vapor pressure @ 20°C (kPa):0.055

Evaporation rate:No information available

Vapor density:No information available

VOC content (g/L):1100

Odor threshold (ppm):No information available

Partition coefficient(n-octanol/water):-1.35

Viscosity:No information available

Miscibility:Miscible with water

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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Solubility:Soluble in EthanolSoluble in EtherSoluble in AcetoneSoluble in ChloroformSoluble in Benzene

Dinitrogen tetraoxideCarbonyl diisothiocyanateAcetanilideMany acyl, aryl, and nonmetal halides (eg acetyl chloride, benzenesulfonylchloride, bromobenzoyl actanilide, cyanuric chloride, iodine pentafluoride,Mg(ClO4)2, CH3Br, NiO4, oxalyl chloride, P2O3, phosphorus trichloride,phosphoryl chloride, silver fluoride, silver difluoride, sodium hydride, sulfurdichloride, disulfur dichloride, sulfurylchloride, tetrachlorosilane, and thionylchloride)

Hazardous decomposition products:

When heated to decomposition it emits toxic fumes. Carbon monoxide. Carbondioxide. Sulfur oxides. Formaldehyde. Methyl mercaptan. Dimethyl sulfide.

Other Information Corrosivity: No information available

Special Remarks on Corrosivity: No information available

11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure

Principal Routes of Exposure:Skin. Ingestion. Eyes.

Acute Toxicity

Component Information

Dimethyl SulfoxideCAS-No. 67-68-5

LD50/oral/rat = 28300 mg/kg Oral LD50 Rat; 14500 mg/kg Oral LD50 RatLD50/oral/mouse = 7920-21400 mg/kgLD50/dermal/rabbit = No information availableLD50/dermal/rat = 40 g/kg Dermal LD50LC50/inhalation/rat = >1600 mg/m3 4 h; > 5.33 mg/L 4 hLC50/inhalation/mouse = No information availableOther LD50 or LC50information = 17400 mg/kg LD50 oral Rat28300 mg/kg LD50 oral Rat

Product Information

LD50/oral/rat =VALUE- Acute Tox Oral = 14500 mg/kg

LD50/oral/mouse =Value - Acute Tox Oral = 7920 mg/kg

LD50/dermal/rabbitVALUE-Acute Tox Dermal = No information available

LD50/dermal/ratVALUE -Acute Tox Dermal = 40000 mg/kg

LC50/inhalation/rat

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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VALUE-Vapor = No information available

VALUE-Gas = No information availableVALUE-Dust/Mist = > 1600 mg/m3 (4-hr.)

LC50/Inhalation/mouseVALUE-Vapor = No information availableVALUE - Gas = No information availableVALUE - Dust/Mist = No information available

Symptoms

Skin Contact: May cause skin irritation. Mild skin irritation. May cause burning or stingingsensation, redness of the skin, inflammation of the skin. May cause itiching. Maycause urticaria (hives). Dimethyl Sulfoxide readily penetrates the skin and maycarry other dissolved chemicals into the body. Skin absorption of DMSO mayresult in garlic-like breath and body odor. If absorbed through skin it may causesystemic effects with symptoms similar to those of ingestion. May cause dyspnea(shortness of breath and difficulty breathing) and cyanosis.

Eye Contact: May cause eye irritation. Mild eye irritation. May cause temporary burningsensation and vasodilation. May cause conjunctivitis. May cause conjunctivalredness. May cause cataracts. May cause corneal opacity. It may cause transientphotophobia and disturbances of vision.

Inhalation May cause irritation of respiratory tract. Inhalation of a high concentration ofvapors may cause headache, dizziness, and sedation.

Ingestion Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea. Maycause constipation. May cause abdominal pain. May cause decreased appetite oranorexia. May affect respiration (difficult or labored breathing resulting inshortness of breath). May affect respiration (respiratory depression). May affecturinary system (kidneys). May cause increase in urine volume. May affect blood(changes in serum composition). It may affect the blood (anemia, eosinophilia). Itmay affect the brain. May affect the cardiovascular system (vasodilation,hypotension, tachycardia, chest pain). May affect behavior/central nervous system(ataxia). May affect behavior/central nervous system (muscle weakness,convulsions). May affect behavior/central nervous system (dizziness, headache).May affect behavior/central nervous system (fatigue, sedation, tremor). May causehypoglycemia (low blood sugar), which is characterized by symptoms such asblurred vision, chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate,confusion, weakness, headache, fainting, hunger, tingling of the hands or feet.May affect liver.

Aspiration hazard No information available.

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Chronic Toxicity Prolonged or repeated ingestion may cause nausea, vomiting, loss of appetite.Prolonged or repeated ingestion may affect the blood (changes in red blood cellcount). Prolonged or repeated ingestion may affect the blood (normocytic anemia).Prolonged or repeated ingestion may affect the kidneys (polyuria (increase in urinevolume, hematuria (blood in the urine), tubular necrosis). Prolonged skin contactmay cause skin irritation and/or dermatitis. Chronic exposure may cause dryingand scaling of the skin.

Sensitization: No information available.

Mutagenic Effects: May affect genetic materialMutations in microorganisms

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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Experiments with bacteria and/or yeast have shown mutagenic effectsMutagenic effects in mammalian somatic cells

Carcinogenic effects: Equivocal tumorigenic agent by Registery of Toxic Effects of ChemicalSubstances (RTECS) criteria.

Components CAS-No. IARC ACGIH -Carcinogens

NTP OSHA HCS -Carcinogens

Australia -Notifiable

CarcinogenicSubstances

Australia -Prohibited

CarcinogenicSubstances

Dimethyl Sulfoxide 67-68-5 Not listed Not listed Not listed Not listed Not listed Not listedACGIH (American Conference of Governmental Industrial Hygienists)

IARC (International Agency for Research on Cancer)

NTP (National Toxicology Program)

OSHA (Occupational Safety and Health Administration of the US Department of Labor)

Reproductive toxicity No data is available

Reproductive Effects: No information availableDevelopmental Effects: No information availableTeratogenic Effects: Showed teratogenic effects in animal experiments

Dimethyl Sulfoxide (DMSO) has been associated with teratogenic and/orembryotoxic effects in animals (hamster, mouse, rat), particularly whenadministered parenterally (intraperitoneal or intravenous routes). DMSO has notbeen shown to be teratogenic or embryotoxic via oral or dermal routes at doselevels that do not produce overt maternal toxicityNo data in humans was available to evaluate the effects of exposure ondevelopment

Specific Target Organ Toxicity

STOT - single exposure No information available.STOT - repeated exposure No information available.Target Organs: Kidneys. Skin. Central nervous system.

12. ECOLOGICAL INFORMATION

Ecotoxicity

Dimethyl Sulfoxide - 67-68-5Freshwater Algae Data: 12350 - 25500 mg/L EC50 Skeletonema costatum 96 hFreshwater Fish Species Data: 34000 mg/L LC50 Pimephales promelas 96 h 1 33 - 37 g/L LC50 Oncorhynchus

mykiss 96 h static 1 40 g/L LC50 Lepomis macrochirus 96 h static 1 41.7 g/L LC50Cyprinus carpio 96 h 1

Water Flea Data: 7000 mg/L EC50 Daphnia species 24 h

Persistence and degradability: Readily biodegradable

Bioaccumulative potential: Potential for bioconcentration in aquatic organisms is low.

Mobility: It is expected to have very high mobility based on estimated Koc.

13. DISPOSAL CONSIDERATIONS

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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Disposal Methods

Waste from residues / unused products:Waste must be disposed of in accordance with Federal, State and Local regulation.

Contaminated packaging:Empty containers should be taken for local recycling, recovery or waste disposal

Components CAS-No. RCRA - F SeriesWastes

RCRA - K SeriesWastes

RCRA - P SeriesWastes

RCRA - U SeriesWastes

Dimethyl Sulfoxide 67-68-5 None None None None

14. TRANSPORT INFORMATION

DOTUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Class No information availablePacking group: No information availableEmergency Response GuideNumber

No information available

Marine Pollutant No data availableDOT RQ (lbs): No information availableSpecial Provisions No Information availableSymbol(s): No information availableDescription: No information available

TDG (Canada)UN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information availableMarine Pollutant No Information availableDescription: No information available

ADRUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availablePacking Group: No information availableSubsidiary Risk: No information available

IMO / IMDGUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information availableMarine Pollutant No information available

RIDUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information available

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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ICAOUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information available

IATAUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information availableERG Code: No information availableSpecial Provisions No information available

15. REGULATORY INFORMATION

International Inventories

Components CAS-No. U.S. TSCA KOREA KECL Philippines(PICCS)

Japan ENCS CHINA Australia(AICS)

EINECS-No.

Dimethyl Sulfoxide 67-68-5 PresentACTIVE

PresentKE-32367

Present Present(2)-1553

Present Present Present200-664-3

U.S. Regulations

Dimethyl SulfoxideNew Jersey RTK Hazardous Substance List: 4145

FDA - Direct Food Additives 21 CFR 172.869 (residual)FDA - 21 CFR - Total Food Additives 172.859, 177.1655, 177.2440

California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986.

Chemicals Known to the State of California to Cause Cancer:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)

Chemicals Known to the State of California to Cause Reproductive Toxicity:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)

Components CAS-No. Carcinogen Developmental Toxicity MaleReproductiveToxicity

FemaleReproductiveToxicity:

Dimethyl Sulfoxide 67-68-5 Not Listed Not Listed Not Listed Not Listed

CERCLA/SARA

Components CAS-No. CERCLA -Hazardous

Substances andtheir Reportable

Quantities

Section 302ExtremelyHazardousSubstancesand TPQs

Section 302ExtremelyHazardous

Substances andRQs

Section 313 -Chemical Category

Section 313 -Reporting

de minimis

Dimethyl Sulfoxide 67-68-5 None None None None None

U.S. TSCA

Components CAS-No. TSCA Section 5(a)2 - ChemicalsWith Significant New Use Rules(SNURS)

TSCA 8(d) -Health and SafetyReporting

Dimethyl Sulfoxide 67-68-5 Not Applicable Not Applicable

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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Canada

WHIMIS 2015 - GHS Classifications

WHMIS 2015 Hazard ClassificationInformation:

.

Component WHMIS 2015 Hazard ClassificationDimethyl Sulfoxide 67-68-5 ( 100 )

Flammable liquids - Category 4: H227 Combustible liquid.

Canada Hazardous Products Regulation This product has been classified according to the hazard criteria of the HPR (HazardousProducts Regulation) and the SDS contains all of the information required by the HPR

Components WHMIS Ingredient Disclosure List -Dimethyl Sulfoxide 1 %

Inventory

Components CAS-No. Canada (DSL) Canada (NDSL)Dimethyl Sulfoxide 67-68-5 Present Not Listed

Components CAS-No. CEPA Schedule I - Toxic SubstancesDimethyl Sulfoxide 67-68-5 Not listedComponents CAS-No. CEPA - 2010 Greenhouse Gases Subject

to Mandatory ReportingDimethyl Sulfoxide 67-68-5 Not listed

EU Classification

EU GHS - SV - CLP 1272/2008

Components CAS-No. EU GHS - SV - CLP (1272/2008)Dimethyl Sulfoxide 67-68-5 No information

EU - CLP (1272/2008)

R-phrase(s)Not determined

S -phrase(s)none

Components CAS-No. Classification ConcentrationLimits:

Safety Phrases

Dimethyl Sulfoxide 67-68-5 No informationThe product is classified in accordance with Annex VI to Directive 67/548/EEC

Indication of danger:not determined

16. OTHER INFORMATION

Preparation Date: 9/15/2014Revision Date: 9/13/2018Prepared by: Sonia Owen

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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Disclaimer: All chemicals may pose unknown hazards and should be used with caution. ThisSafety Data Sheet (SDS) applies only to the material as packaged. If this productis combined with other materials, deteriorates, or becomes contaminated, it maypose hazards not mentioned in this SDS. The physical properties reported in thisSDS are obtained from the literature and do not constitute product specifications.Information contained herein does not constitute a warranty, whether expressed orimplied, as to the safety, merchantability or fitness of the goods for a particularpurpose. Spectrum Chemicals & Laboratory Products, Inc. assumes noresponsibility for results obtained or for incidental or consequential damages,including lost profits, arising from the use of these data. No warranty againstinfringement of any patent, copyright or trademark is made or implied. It shall bethe user's responsibility to develop proper methods of handling and personalprotection based on the actual conditions of use. While this SDS is based ontechnical data judged to be reliable, Spectrum assumes no responsibility for thecompleteness or accuracy of the information contained herein.

End of Safety Data Sheet

Product code: D1258 Product name: DIMETHYLSULFOXIDE, USP

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Spectrum Chemical Mfg Corp

Corporate Headquarters: West Coast Facility: 769 Jersey Ave. 14422 S. San Pedro St. New Brunswick, NJ 08901 Gardena, CA 90248

732.214.1300 310.516.8000

Manufacturing Process Flowchart

Dimethyl Sulfoxide, USP - D1258

H2S, MeOH

Gas phase thioetherification

DMS Purification

DMS Feed

O2, N2O4

Crude DMSO

DMSO purification

DMSO USP production process

Packaging andrelease testing

C O R P O R A T E H E A D Q U A R T E R S

769 Jersey Avenue

New Brunswick, NJ 08901

PHONE 732.214.1300

FAX 732.246.7132

A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY

W E S T C O A S T F A C I L I T Y

14422 South San Pedro Street

Gardena, California 90248

PHONE 310.516.8000

FAX 310.516.9843

w w w . s p e c t r u m c h e m i c a l . c o m

January 08, 2019 Certification of Compliance with current Good Manufacturing Practices Dear Valued Customer: Spectrum Chemical Mfg Corp certifies that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively. Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824 Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at mdang@spectrumchemical.com if I may be of further assistance. Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance

July 25, 2019

Certification of Compliance with current Good Manufacturing Practices

Dear Valued Customer:

Spectrum Chemical Mfg Corp certifies that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.

Catalog Number Product Name D1258 Dimethyl Sulfoxide, USP

Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:

Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum-Shanghai, China: 03006174778

Thank you for your interest in Spectrum products. If we may be of further assistance, please feel free to contact the Quality Assurance department at 310-516-8000 or via email at qualityassurance@spectrumchemical.com

Sincerely,

Oralia Chavez Quality Assurance Specialist

April 8, 2016 RE: Dimethyl Sulfoxide, USP – D1258 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. Spectrum Chemical Mfg Corp. shares your concern regarding Bovine Spongiform Encephalopathy (BSE). This will certify that the following chemical is BSE/TSE free. Dimethyl Sulfoxide, USP – D1258 If you have any further questions, please contact us by telephone at 1-800-772-8786 or 1-310-516-8000 extension 5741, or by email at techservices@spectrumchemical.com. Sincerely, Rose Briceño Technical Services Spectrum Chemical Mfg Corp. This document has been produced electronically and is valid without a signature

April 11, 2016 RE: Dimethyl Sulfoxide, USP – D1258 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Milk, Egg, Fish, Shellfish, Tree nuts, Wheat, Peanuts, Soy, Cereals containing Gluten, Celery, Mustard, Sesame Seed). Dimethyl Sulfoxide, USP – D1258 If you have any further questions, please contact us by telephone at 1-800-772-8786 or 1-310-516-8000 extension 5471, or by email at techservices@spectrumchemical.com. Sincerely, Rose Briceño Technical Services Spectrum Chemical Mfg Corp. This document has been produced electronically and is valid without a signature

April 11, 2016 RE: Dimethyl Sulfoxide, USP – D1258 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg Corp. understand the concern regarding the presence of aflatoxins in raw materials. Please be assured that the product does not contain nor is it manufactured using aflatoxins. Dimethyl Sulfoxide, USP – D1258 If you have any further questions, please contact us by telephone at 1-800-772-8786 or 1-310-516-8000 extension 5471, or by email at techservices@spectrumchemical.com. Sincerely, Rose Briceño Technical Services Spectrum Chemical Mfg Corp. This document has been produced electronically and is valid without a signature

Certificate Of Analysis

Item Number D1258 Lot Number 1ID0632

Item Dimethyl Sulfoxide, USP Manufacturer Lot USP180124

CAS Number 67-68-5 Manufacturer Code 5567

Molecular Formula C2H6OS Molecular Weight 78.13

Test Specification Resultmin max

99.9% 100.0 %

1.095 1.101 1.098

1.4755 1.4775 1.4773

0.01 % 0.00 %

0.1 % 0.0 %

0.1 % <0.03 %

TO PASS TEST PASSES TEST

TO PASS TEST PASSES TEST

AS REPORTEDNO ELEMENTAL

IMPURITIESPRESENT

TO PASS TEST PASSES TEST

CERTIFIED HALAL

28-FEB-2022

02-FEB-2018

CLEARCOLORLESS

LIQUID

TO PASS TEST NO RESIDUALSOLVENTS USED

Spectrum Chemical Mfg Corp

14422 South San Pedro Street

Gardena 90248 CA

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 hazardousmaterial 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 understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing 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 dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.

Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers andsuppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer orsupplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for theoriginal Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum'sQuality Department at 1-800-772-8786.

Chemical Emergency: (800)424-9300*49452D1258062233A0A* D1258 4 L

Dimethyl Sulfoxide(DMSO; Methyl Sulfoxide)

U.S.P.CAS 67-68-5

CAUTION: For manufacturing, processing, repacking, or for prescription compounding. Rx only.Read and understand the label and Safety Data Sheet (SDS) prior to use.

WARNING• Causes eye irritation • Combustible liquid.• Keep away from flames and hot surfaces • No smoking • Wear protective gloves, eye protection, face protection • Wash face, hands and any exposed skin thoroughly after handling.FIRST AID: 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.IN CASE OF FIRE: Use CO2, dry chemical powder or appropriate foam to extinguish.

KEEP FROM CHILDREN

R 8/D9GHS A Lot No. 062233

C2H6OS F.W. 78.13

Assay (Anhydrous Basis) .................. Min. 99.9%Specific Gravity ................................ 1.095-1.101Refractive Index ........................... 1.4755-1.4775

MAXIMUM LIMITSAcidity ...............................................To pass testWater .......................................................... 0.1%Ultraviolet Absorbance ......................To pass testNonvolatile Residue ..........................To pass testRelated Compounds ..........................To pass testResidual Solvents .............................To pass test

LIGHT SENSITIVE, HYGROSCOPIC: Keep tightly closed in light-resistant containers.

www.SpectrumChemical.com

Rete

st D

ate:

03-

25-2

025

SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901

Expiration Information

Lot Number

Bar CodeWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade

Size/Quantity

Chemical Abstracts Service (CAS) Registry Number

Caution Information

Toll-Free 24-Hour Chemical Emergency Telephone Number

Empirical Formula, Formula Weight and Technical Specifications Panel

B

J

D

A

I

C

Storage Color Band

This color-coded band indicates the hazard most likely to be posed by that material under storage conditions. The criteria used to assign band colors have been established by the Storage Code working group of the Society for Chemical Hazard Communication (SCHC). It is recommended that like colors be stored together, unless otherwise stated, based on the color codes indicated to the right. However, it is the responsibility of the customer to check with their local fire department for possible conflicts with our recommendations when storing hazardous chemicals.

H

F

G

K

E

YELLOW: Oxidizer

RED: Flammable

GREEN: General Storage

BLUE: Health Hazard

WHITE: Corrosive

L

Label Legend

The Spectrum label presents technical and safety information in an easily understood format. Our technical specialists stay abreast of the latest requirements of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS), as well as the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and other government regulatory agencies in order to ensure compliance, accuracy and concise hazard communication.

F

C

H

G

B

D

E

IA

K

LJ

Spectrum Chemical Mfg Corp

Corporate Headquarters: West Coast Facility:

769 Jersey Ave. 14422 S. San Pedro St.

New Brunswick, NJ 08901 Gardena, CA 90248

732.214.1300 310.516.8000

Label Information

C O R P O R A T E H E A D Q U A R T E R S

769 Jersey Avenue

New Brunswick, NJ 08901

PHONE 732.214.1300

FAX 732.246.7132

A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY

W E S T C O A S T F A C I L I T Y

14422 South San Pedro Street

Gardena, California 90248

PHONE 310.516.8000

FAX 310.516.9843

w w w . s p e c t r u m c h e m i c a l . c o m

February 1, 2019 RE: Lot Numbering System Dear Valued Customer: This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production. The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned.

Example: ZI0928 = The 928th material produced in California in September 2010 The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility: 1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility 4 = Pharmacy, NJ Facility The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned.

Example: 2AA0706 = The 706th material produced in New Jersey in January 2011 Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at qualityassurance@spectrumchemical.com if we may be of further assistance.

Sincerely,

Howard Lau, Quality Assurance Specialist

25.July.2019

Stability – Shelf Life Guidance Product Covered: D1258, Dimethyl Sulfoxide, USP Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, D1258, Dimethyl Sulfoxide, USP, is assigned a 48 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures. Adan R. Hernandez Quality Control Manager

Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605

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