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 

Ver4.04  6.February.2019 

Scientific Documentation PO125, Polyethylene Glycol 3350, 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

6.February.2019

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6.February.2019

Specification for Polyethylene Glycol 3350, USP(PO125)

Item Number PO125

Item Polyethylene Glycol 3350, USP

CAS Number 25322-68-3

Molecular Formula H(OCH2CH2)nOH

Molecular Weight

MDL Number

Synonyms Macrogol 3350; PEG-75 ; Base B ; Macrogol 3350 ; PEG-75

Test SpecificationMin Max

ASSAY (ANHYDROUS BASIS) 97.0 103.0 %APPARENT WEIGHT-AVERAGE MOLECULAR WEIGHT 3015 3685POLYDISPERSITY 1.00 1.16HYDROXYL VALUE 30 38ACIDITY AND ALKALINITY, pH 4.5 7.5RESIDUE ON IGNITION 0.1 %ETHYLENE GLYCOL 0.062 %SUM OF ETHYLENE & DIETHYLENE GLYCOL 0.2 %FORMALDEHYDE 15 μg/gSUM OF FORMALDEHYDE & ACETALDEHYDE 200 μg/gFREE ETHYLENE OXIDE 1 μg/gFREE 1,4-DIOXANE 10 μg/gELEMENTAL IMPURITIES:NICKEL (Ni) AS REPORTEDCHROMIUM (Cr) AS REPORTEDWATER DETERMINATION 1.0 %

IDENTIFICATION A SPECTRUM MATCHESREFERENCE

IDENTIFICATION BRETENTION TIMECORRESPONDS TO

STANDARDRETEST DATEDATE OF MANUFACTUREAPPEARANCERESIDUAL SOLVENTS: AS REPORTED

SAFETY DATA SHEETPreparation Date: 03/17/2015 Revision Date: 08/21/2018 Revision Number: G3

1. IDENTIFICATIONProduct identifier

Product code: PO125Product Name: POLYETHYLENE GLYCOL 3350, USP

Other means of identificationSynonyms: 1,2-Ethanediol homopolymer

Ethoxylated 1,2-ethanediolEthylene glycol homopolymerEthylene glycol polymerGlycols, polyethyleneOxyethylene polymerPEG 3350PEG-75Macrogol 3350Poly(oxy-1,2-ethanediyl, alpha-hydro-omega-hydroxy-Polyoxyethylene etheralpha-Hydro-omega-hydroxypoly(oxy-1,2-ethanediyl)alpha-Hydro-omega-hydroxypoly(oxyethylene)

CAS #: 25322-68-3RTECS # TQ3500000CI#: Not available

Recommended use of the chemical and restrictions on useRecommended use: No information available.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.comEmergency 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 not considered hazardous according to the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Not a dangerous substance or mixture according to the Globally Harmonized System (GHS)

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

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Label elements

Hazards not otherwise classified (HNOC)Not Applicable

Other hazards Not available

3. COMPOSITION/INFORMATION ON INGREDIENTS

Components CAS-No. Weight %Polyethylene Glycol 3350 25322-68-3 100

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. 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 artificialrespiration. Get medical attention.

Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Consult a physician if necessary.

Most important symptoms and effects, both acute and delayed

Symptoms Mild eye irritationMild skin irritation

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: Carbon dioxide (CO2). Dry chemical. Alcohol-resistant

foam. Water spray.

Unsuitable Extinguishing Media: No information available.

Not classified

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

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Specific hazards arising from the chemical

Hazardous Combustion Products: Carbon Monoxide, Carbon Dioxide.

Specific hazards: May be combustible at high temperatures.

Special Protective Actions for Firefighters

Specific Methods: No information available.

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

7. HANDLING AND STORAGE

Precautions for safe handling

Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation. Keep away from incompatiblematerials.

Safe Handling AdviceWear personal protective equipment. Use only in well-ventilated areas. Avoid contact with skin, eyes and clothing.Keep away from heat and sources of ignition. Do not ingest. Do not breathe dust. Handle in accordance with goodindustrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities

Technical Measures/Storage Conditions:Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in the originalcontainer. Store away from incompatible materials. Flushed with nitrogen.

Incompatible Materials:Oxidizing agentsAcidsAlkalis

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Personal Precautions: Ensure adequate ventilation. Avoid contact with skin, eyes and clothing. Use personalprotective equipment. Remove all sources of ignition.

Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent product from enteringdrains.

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 preventspreading.

Methods for cleaning up Sweep up and shovel into suitable containers for disposal. Clean contaminatedsurface thoroughly.

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

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Control parameters

National occupational exposure limits

United States

Components CAS-No. OSHA NIOSH ACGIH AIHA WEELPolyethylene Glycol

335025322-68-3 None None None 10 mg/m3 TWA

Canada

Components CAS-No. Canada - Alberta Canada - BritishColumbia

Canada - Ontario Canada - Quebec

Polyethylene Glycol3350

25322-68-3 None None None None

Australia and Mexico

Components CAS-No. Australia MexicoPolyethylene Glycol 3350 25322-68-3 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: Safety glasses with side-shields.

Skin and body protection: Chemical resistant apronLong sleeved clothingGloves

Respiratory protection: Effective dust mask. Be sure to use an approved/certified respirator or equivalent.

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

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical state:Solid

Appearance:Powder. Granular powder.

Color:White.

Odor:Mild.

TasteNo information available.

Formula:H(OCH2CH2)nOH

Molecular/Formula weight (g/mole):3015-3685 g/mol

Flammability:No information available

Flashpoint (°C/°F):246°C/ 475°F

Flash Point Tested according to:Closed cup

Autoignition Temperature (°C/°F):No information available

Lower Explosion Limit (%):No information available

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

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10. STABILITY AND REACTIVITYReactivityReactive with oxidizing agentsReactive with acidsReactive with alkalis

Chemical stability

Stability: Stable under recommended storage conditions.

Possibility of Hazardous Reactions: Hazardous polymerization does not occur

Conditions to avoid: Heat. Ignition sources. Incompatible materials.

Incompatible Materials: Oxidizing agentsAcidsAlkalis

Hazardous decompositionproducts:

Carbon monoxide. Carbon dioxide.

Other InformationCorrosivity: No information available

Special Remarks on Corrosivity: No information available

11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure

Principal Routes of Exposure:Ingestion. Inhalation. Skin.

Acute Toxicity

Component Information

Upper Explosion Limit (%):No information available

Melting point/range(°C/°F):53-57°C/ 127-135°F

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

Boiling point/range(°C/°F):>200°C/ >392°F

Bulk density:No information available

Density (g/cm3):1.0926

Specific gravity:1.11

pH:4.5-7.5 (5% aqueous solution)

Vapor pressure @ 20°C (kPa):<0.01 mmHg

Evaporation rate:No information available

Vapor density:No information available

VOC content (g/L):No information available

Odor threshold (ppm):No information available

Partition coefficient(n-octanol/water):No information available

Viscosity:No information available

Miscibility:No information available

Solubility:Solubility in Water: 61.5% @ 15°C;67% at 20°C

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

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Polyethylene Glycol 3350CAS-No. 25322-68-3

LD50/oral/rat = 22 g/kg Oral LD50 Rat; 28 g/kg Oral LD50 Rat(LOLI)50 g/kg (RTECS)LD50/oral/mouse = No information availableLD50/dermal/rabbit = > 20 mL/kg; > 20 g/kgLD50/dermal/rat = No information availableLC50/inhalation/rat = No information availableLC50/inhalation/mouse = No information availableOther LD50 or LC50information = No information available

Product Information

LD50/oral/rat =VALUE- Acute Tox Oral = 22000 mg/kg

LD50/oral/mouse =Value - Acute Tox Oral = No information available

LD50/dermal/rabbitVALUE-Acute Tox Dermal = > 20000 mg/kg

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

LC50/inhalation/ratVALUE-Vapor = No information availableVALUE-Gas = No information availableVALUE-Dust/Mist = No information available

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

Symptoms

Skin Contact: May cause mild to moderate skin irritation.

Eye Contact: Mild eye irritation.

Inhalation At room temperature, exposure to vapor is minimal due to low volatility. A singleexposure is not likely to be hazardous.

Ingestion Low hazard. May cause nausea. May cause vomiting.

Aspiration hazard No information available.

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

Chronic Toxicity No information available.

Sensitization: No information available.

Mutagenic Effects: No information available

Carcinogenic effects: Not considered carcinogenic.

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

6 / 11

Components CAS-No. IARC ACGIH -Carcinogens

NTP OSHA HCS -Carcinogens

Australia -Notifiable

CarcinogenicSubstances

Australia -Prohibited

CarcinogenicSubstances

Polyethylene Glycol 3350 25322-68-3 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: No information available

Specific Target Organ Toxicity

STOT - single exposure No information available.STOT - repeated exposure No information available.Target Organs: No information available.

12. ECOLOGICAL INFORMATION

Ecotoxicity

Ecotoxicity effects: No data available.

Polyethylene Glycol 3350 - 25322-68-3Freshwater Fish Species Data: LC50, fathead minnow (Pimephales promelas), 96 h: 58,900 mg/lWater Flea Data: EC50, water flea Daphnia magna, 48 h, immobilization: 22,100 mg/l

Microtox Data EC50, bacteria, Growth inhibition, 16 h: > 10,000 mg/l

Persistence and degradability: Readily biodegradable

Bioaccumulative potential: No information available.

Mobility: No information available.

13. DISPOSAL CONSIDERATIONS

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

Polyethylene Glycol 3350 25322-68-3 None None None None

14. TRANSPORT INFORMATION

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

7 / 11

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

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 available

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

8 / 11

ERG 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.

Polyethylene Glycol3350

25322-68-3 PresentACTIVE

PresentKE-20228

Present Present(7)-129

Present Present Not present

U.S. Regulations

Polyethylene Glycol 3350Minnesota - Hazardous Substance List: Present

FDA - Direct Food Additives 21 CFR 172.210, 21 CFR 172.820, 21 CFR 173.310, 21 CFR 173.340 (molecular weight200-9500)

FDA - 21 CFR - Total Food Additives 172.210, 172.820, 173.310, 173.340, 175.105, 175.300, 176.180, 178.3750, 73.1(molecular weight 200-9500)

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

Chemicals Known to the State of California to Cause Cancer:

WARNING: This product can expose you to chemicals including (see table below) which is (are) known to the State of California to causecancer. For more information go to www.p65warnings.ca.gov.

Chemicals Known to the State of California to Cause Reproductive Toxicity:

WARNING: This product can expose you to chemicals including (see table below) which is (are) known to the State of California to cause birthdefects or other reproductive harm. For more information go to www.p65warnings.ca.gov.

Components CAS-No. Carcinogen Developmental Toxicity MaleReproductiveToxicity

FemaleReproductiveToxicity:

Polyethylene Glycol 3350 25322-68-3 May containtrace amountsof Ethyleneoxideand1,4-Dioxane(<= 1ug/g and<= 10 ug/g,respectively)

May contain traceamounts of Ethyleneoxide(<= 1 ug/g)

May contain traceamounts ofEthylene oxide(<=1 ug/g)

May contain traceamounts ofEthylene oxide(<=1 ug/g)

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

Polyethylene Glycol3350

25322-68-3 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

Polyethylene Glycol 3350 25322-68-3 Not Applicable Not Applicable

Canada

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

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WHIMIS 2015 - GHS Classifications

WHMIS 2015 Hazard ClassificationInformation:

Not a dangerous product according to HPR classification criteria.

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

WHMIS 1988 Hazard ClassNon-controlled

Canada Controlled Products Regulation:This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDScontains all of the information required by the CPR.

Inventory

Components CAS-No. Canada (DSL) Canada (NDSL)Polyethylene Glycol 3350 25322-68-3 Present Not Listed

Components CAS-No. CEPA Schedule I - Toxic SubstancesPolyethylene Glycol 3350 25322-68-3 Not listedComponents CAS-No. CEPA - 2010 Greenhouse Gases Subject

to Mandatory ReportingPolyethylene Glycol 3350 25322-68-3 Not listed

EU Classification

EU GHS - SV - CLP 1272/2008

Components CAS-No. EU GHS - SV - CLP (1272/2008)Polyethylene Glycol 3350 25322-68-3 No information

EU - CLP (1272/2008)

R-phrase(s)not determined (not applicable)

S -phrase(s)none

Components CAS-No. Classification ConcentrationLimits:

Safety Phrases

Polyethylene Glycol 3350 25322-68-3 No informationThe product is classified in accordance with Annex VI to Directive 67/548/EEC

Indication of danger:None.

16. OTHER INFORMATION

Preparation Date: 03/17/2015Revision Date: 08/21/2018Prepared by: Sonia Owen

Product code: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

10 / 11

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: PO125 Product name: POLYETHYLENEGLYCOL 3350, USP

11 / 11

Manufacturer Product Covered: PO125, Polyethylene Glycol 3350, USP

Spectrum takes ownership as the manufacturer for the Spectrum product listed above and provides full quality assurance, customer service, and technical product support.

While information concerning the raw material manufacturer of our starting materials is considered proprietary, such information can be made available upon request contingent on demonstration of business volume justification and successful execution of confidential disclosure agreement (CDA).

Requests for disclosure of proprietary raw material manufacturer information may be submitted to the assigned account representative for consideration.

Sincerely,

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

6.February.2019

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

April 12, 2018 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,

MichaelDangDirector,QualitySystems&GMPCompliance

February 6, 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 PO125 Polyethylene Glycol 3350, 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

June 8, 2016 Re: Polyethylene Glycol 3350, NF- PO125 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding Bovine Spongiform Encephalopathy (BSE). Please be assured that the chemical Polyethylene Glycol 3350, NF- PO125 is BSE/TSE free. If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at techservices@spectrumchemical.com. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

June 8, 2016 Re: Polyethylene Glycol 3350, NF- PO125 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. 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; Sulfur dioxide and sulfites at concentrations of more than 10 mg/kg or 10 mg/liter expressed as SO2; Lupin; Tree nuts; Mollusks; Wheat; Peanuts; Soy; Cereals containing Gluten; Celery; Mustard; Sesame Seed). Polyethylene Glycol 3350, NF- PO125

If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at techservices@spectrumchemical.com. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

June 8, 2016 Re: Polyethylene Glycol 3350, NF- PO125 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 Aflatoxins in raw materials. To the best of our knowledge, Aflatoxin or Aflatoxin-related substances are not likely nor expected to be present in this product mentioned below. However, the manufacturing site does not routinely perform any analytical testing to verify the presence or absence of Aflatoxins in this product. Polyethylene Glycol 3350, NF- PO125 If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at techservices@spectrumchemical.com. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

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

Chemical Emergency: (800)424-9300*49452PO125062233LVA* PO125 12 KG

Polyethylene Glycol 3350

(Macrogol 3350; PEG-75)N.F.

CAS 25322-68-3CAUTION: For manufacturing, processing or repacking. Read and understand the label and Safety Data Sheet (SDS) prior to use.

USE CARE: This material has been evaluated per GHS/OSHA criteria and is not classified as hazardous. All chemicals may pose unknown hazards and must be used with caution. Use personal protection and safe handling methods consistent with proper workplace safety practices. Consult SDS for additional properties and precautions. If adverse reaction occurs seek medical attention.

KEEP FROM CHILDREN

G 13/E1GHS A Lot No. 062233

H(OCH2CH2)nOHAddition Polymer of Ethylene Oxide and Water.

Average Molecular Weight .........................................12Completeness and Color of Solution .......... To pass testActual Viscosity @ 98.9 ±0.3°C (210°F) ............. 12 cStpH of a 5% Solution @ 25°C .............................. 4.5-7.5

MAXIMUM LIMITSResidue on Ignition ............................................... 0.1%Heavy Metals ....................................................... 5 ppmFree Ethylene Oxide ........................................... 10 µg/gFree 1,4-Dioxane ............................................... 10 µg/gResidual Solvents ...................................... To pass test

WARNING: This product contains a chemical known to the State of California to cause cancer.

WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.

FLUSHED WITH NITROGEN

www.SpectrumChemical.com

Rete

st D

ate:

03-

31-2

025

Empirical Formula, Formula Weight and Technical Specifications Panel

Expiration Information

Lot Number

Kosher Certified by Kosher Supervision of America (KSA).

Bar CodeGHS Hazard PictogramsWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade

Size/Quantity

Chemical Abstracts Service (CAS) Registry Number

Caution Information

DOT Shipping Information

Toll-Free 24-Hour Chemical Emergency Telephone Number

B

K

D

A

I

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F

G

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YELLOW: Oxidizer

RED: Flammable

GREEN: General Storage

BLUE: Health Hazard

WHITE: Corrosive

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.

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Label Legend

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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.

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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

Label Information

C

Certificate Of Analysis

Item Number PO125 Lot Number 2HA0368

Item Polyethylene Glycol 3350, USP

CAS Number 25322-68-3Molecular Formula H(OCH2CH2)nOH Molecular Weight

Test Specification Resultmin max

97.0 103.0 % 100.34 %

3015 3685 3351

1.00 1.16 1.00 -- 1.1630 38 344.5 7.5 6.0

0.1 % <0.1 %TO PASS TEST PASSES TESTTO PASS TEST PASSES TEST

1 μg/g 0 μg/g10 μg/g 0 μg/g

.AS REPORTED <0.1 μg/gAS REPORTED <0.1 μg/g

1.0 % 0.2 %TO PASS TEST PASSES TESTTO PASS TEST PASSES TEST

26-JUN-202026-JUN-2017

WHITE POWDERTO PASS TEST PASSES TEST

<620 ppm<5000 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 hazardousmaterial training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical.

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

6.February.2019

6.February.2019

Stability – Shelf Life Guidance Product Covered: PO125, Polyethylene Glycol 3350, USP Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, PO125, Polyethylene Glycol 3350, USP, is assigned a 36 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