D1258, Dimethyl Sulfoxide, USP - Spectrum Chemical...Specification for Dimethyl Sulfoxide, USP...
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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.
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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.
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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
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New Brunswick, NJ 08901
PHONE 732.214.1300
FAX 732.246.7132
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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 [email protected] 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 [email protected]
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 [email protected]. 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 [email protected]. 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 [email protected]. 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.
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SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901
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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.
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YELLOW: Oxidizer
RED: Flammable
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BLUE: Health Hazard
WHITE: Corrosive
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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
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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 [email protected] 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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