po185, potassium iodide, usp - spectrum chemical10. stability and reactivity reactivity reactive...

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 26.July.2019

Scientific Documentation PO185, Potassium Iodide, 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 [email protected]

26.July.2019

PO185, Methylcellulose, Potassium Iodide, USP

Table of Contents

Product Specification

Safety Data Sheet (SDS)

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

Kosher Certificate

Halal Certificate

Specification for Potassium Iodide, USP (PO185)

Item Number PO185

Item Potassium Iodide, USP

CAS Number 7681-11-0

Molecular Formula KI

Molecular Weight 166.00

MDL Number

Synonyms

Test SpecificationMin Max

ASSAY 99.0 101.5 %

ALKALINITY NO COLOR IS PRODUCED

LOSS ON DRYING 1.0 %

IODATE 4 μg/g

NITRATE, NITRITE, AND AMMONIANO BLUE COLORATION OF

THE PAPER ISDISCERNIBLE

THIOSULFATE, BARIUM NO TURBIDITY DEVELOPSWITHIN 1 MIN.

ELEMENTAL IMPURITIES AS REPORTED

IDENTIFICATION (A) POSITIVE FOR POTASSIUM

IDENTIFICATION (B) POSITIVE FOR IODIDE

CERTIFIED KOSHER

CERTIFIED HALAL

RETEST DATE

DATE OF MANUFACTURE

APPEARANCE

RESIDUAL SOLVENTS AS REPORTED

https://www.spectrumchemical.comhttps://www.spectrumchemical.com/OA_HTML/chemical-products_Potassium-Iodide-USP_PO185.jsp?minisite=10020&respid=22372https://www.spectrumchemical.com/OA_HTML/chemical-products_Potassium-Iodide-USP_PO185.jsp?minisite=10020&respid=22372https://www.spectrumchemical.com/OA_HTML/chemical-cas_Potassium-Iodide-USP_7681-11-0.jsp?pCasName=Potassium-Iodide-USP

SAFETY DATA SHEETPreparation Date: 01/22/2015 Revision Date: 08/06/2018 Revision Number: G2

1. IDENTIFICATIONProduct identifier

Product code: PO185Product Name: POTASSIUM IODIDE, USP

Other means of identification Synonyms: No information availableCAS #: 7681-11-0RTECS # TT2975000CI#: Not available

Recommended use of the chemical and restrictions on use Recommended 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.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 2BSkin sensitization Category 1BReproductive toxicity Category 2Specific target organ toxicity (single exposure) Category 3Specific target organ toxicity (repeated exposure) Category 1

Label elements

Danger

Product code: PO185 Product name: POTASSIUM IODIDE,USP

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Hazard statementsCauses eye irritationMay cause an allergic skin reactionSuspected of damaging fertility or the unborn childMay cause respiratory irritationCauses damage to organs through prolonged or repeated exposure

Hazards not otherwise classified (HNOC) Not Applicable

Other hazards Not available

Precautionary Statements - PreventionObtain special instructions before useDo not handle until all safety precautions have been read and understoodWash face, hands and any exposed skin thoroughly after handlingWear protective gloves/protective clothing/eye protection/face protectionContaminated work clothing must not be allowed out of the workplaceUse only outdoors or in a well-ventilated areaDo not breathe dust/fume/gas/mist/vapors/sprayDo not eat, drink or smoke when using this product

Precautionary Statements - Response

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.IF ON SKIN: Wash with plenty of waterIf skin irritation or rash occurs: Get medical advice/attentionWash contaminated clothing before reuseIF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if youfeel unwell.

Precautionary Statements - StorageStore locked upStore in a well-ventilated place. Keep container tightly closed

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

3. COMPOSITION/INFORMATION ON INGREDIENTS

Components CAS-No. Weight %Potassium Iodide 7681-11-0 100

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 irritation develops. Consult a physician if necessary.

Eye Contact: Flush eyes with water for 15 minutes. Get medical attention if irritation occurs. If symptomspersist, call a physician.


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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. Consult a physician if necessary.

Most important symptoms and effects, both acute and delayed

Symptoms Causes eye irritationEye contact may result in redness or painMay cause an allergic skin reactionMay cause irritation of respiratory tractCauses digestive (gastrointestinal) tract irritationIngestion may cause nausea, vomiting, and diarrheaMay affect respirationDyspnea (Shortness of breath and difficulty breathing)It may affect the thyroidCentral nervous system effectsMay cause headacheDrowsinessSomnolenceMay cause iodism

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: The product is not flammable. If it is involved in a fire,

extinguish the fire using an agent suitable for the type ofsurrounding fire.

Unsuitable Extinguishing Media: No information available.

Specific hazards arising from the chemical

Hazardous Combustion Products: No information available.

Specific hazards: No information available.

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


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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. Avoid dust formation. Keep away from incompatiblematerials.

Safe Handling AdviceWear personal protective equipment. Avoid contact with skin, eyes and clothing. Keep away from heat andsources of ignition. Avoid dust formation. Do not ingest. Do not breathe vapors/dust. Handle in accordance withgood industrial 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. Protect from moisture. Moisture sensitive. Protect from light.Sensitive to light. Store in light-resistant containers.

Incompatible Materials:Alkali MetalsMetalsOrganic materialsReducing agentsStrong acidsOxidizing agentsMercurous chloride

8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters

National occupational exposure limits

United States

Components CAS-No. OSHA NIOSH ACGIH AIHA WEELPotassium Iodide 7681-11-0 None None None None

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. Use personalprotective equipment. Avoid contact with skin, eyes and clothing. Do not touch damagedcontainers or spilled material unless wearing appropriate protective clothing. Avoidbreathing dust.

Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent product from enteringdrains. 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. Cover with plastic sheet to preventspreading.

Methods for cleaning up


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

Canada

Components CAS-No. Canada - Alberta Canada - BritishColumbia

Canada - Ontario Canada - Quebec

Potassium Iodide 7681-11-0 None None None None

Australia and Mexico

Components CAS-No. Australia MexicoPotassium Iodide 7681-11-0 None None

Appropriate engineering controls

Engineering measures to reduce exposure: Ensure adequate ventilation. Use process enclosures,local exhaust ventilation, or other engineering controls tokeep airborne levels below recommended exposure limits.If user operations generate dust, fume or mist, useventilation to keep exposure to airborne contaminantsbelow the exposure limit.

Individual protection measures, such as personal protective equipment

Personal Protective Equipment

Eye protection: Safety glasses with side-shields or Goggles

Skin and body protection: Long sleeved clothingChemical resistant apronGloves

Respiratory protection: Effective dust mask. Use a dust respirator under conditions where exposure tothe substance is apparent (e.g. generation of high concentration of dust (dustclouds) , inadequate ventilation, development of respiratory tract irritation), andengineering controls are not feasible. Be sure to use an approved/certifiedrespirator 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

Physical state:Solid

Appearance:Crystals. Crystalline. Granular.Granular powder.

Color:White.

Odor:Odorless.

TasteBitter. Saline.

Formula:KI

Molecular/Formula weight (g/mole):166.00

Flammability:No information available

Flashpoint (°C/°F):No information available.

Flash Point Tested according to:Not available

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

Lower Explosion Limit (%):No information available

Upper Explosion Limit (%):No information available

Melting point/range(°C/°F):681°C/1257.8°F

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

Boiling point/range(°C/°F):


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10. STABILITY AND REACTIVITYReactivity Reactive with acidsReactive with metalsReactive with oxidizing agentsReacts with reducing agentsReactive with organic materialsMercurous chloride in the presence of an excess of potassium iodide produces metallic mercury and mercuric iodide, the latterforming the soluble double salt, potassium mercuric iodideReacts violently with strong oxidizers (bromotrifluorides, chlorotrifluorides, fluorine perchlorate), metallic salts.Attacks metals inmoist environments.Also incompatible with salts of alkaloids, chloral hydrate, calomel (mercurous chloride), potassium chlorate,tartaric and other acids, oxidants, diazonium salts, charcoal, ozone, strong reducers, alkali metals, metals (brass, aluminummagnesium, zinc, cadmium, copper, tin, nickel, steel)

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. Exposure to light. Exposure tomoisture. Becomes yellow on exposure to air. Light and moisture accelerate thedecompositon.

Incompatible Materials: Alkali MetalsMetalsOrganic materialsReducing agentsStrong acidsOxidizing agentsMercurous chloride

Hazardous decomposition products:

Hydrogen iodide. Oxides of potassium. Iodine.

Other Information Corrosivity: No information available

Special Remarks on Corrosivity: No information available

1330°C/2426°F Bulk density:No information available

Density (g/cm3):No information available

Specific gravity:3.1

pH:No information available

Vapor pressure @ 20°C (kPa):No information available

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:Easily soluble in cold waterEasily soluble in waterSoluble in MethanolPartially soluble in acetone


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11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure

Principal Routes of Exposure:Ingestion. Inhalation.

Acute Toxicity

Component Information

Potassium IodideCAS-No. 7681-11-0

LD50/oral/rat = No information availableLD50/oral/mouse = 1862 mg/kg, LDLoLD50/dermal/rabbit = No information availableLD50/dermal/rat = No information availableLC50/inhalation/rat = No information availableLC50/inhalation/mouse = No information availableOther LD50 or LC50information = 916 mg/kg, oral, rabbit, LDLo

Product Information

LD50/oral/rat =VALUE- Acute Tox Oral = No information available

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

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

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 skin irritation. It may cause mild skin irritation. May cause allergiccontact dermatitis.

Eye Contact: Causes eye irritation. Mild eye irritation.

Inhalation May cause respiratory tract and mucous membrane irritation and a productivecough. May cause pulmonary edema and inflammation of the tonsils.

Ingestion Causes gastrointestinal tract irritation with nausea, vomiting and diarrhea. Mayaffect behavior(somnolence, muscle weakness), respiration (dyspnea).


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Serum-sickness type of hypersensitivity such as fever, arthralgia, lymph nodeenlargement , and eosinophilia may appear. Thrombotic thrombocytopenicpurpura, and fatal periarteritis nodosa attributed to hypersensitivity to iodide hasbeen described.

Aspiration hazard No information available.

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

Chronic Toxicity Can lead to iodism characterized by salivation, metallic taste, sore mouth, nausea,vomiting, epigastric pain, diarrhea, nasal discharge, sneezing, conjunctivitis, fever,headache, laryngitis, bronchitis, stomatits, parotitis, anemia, and skin rashes.Chronic ingestion may also affect metabolism (anorexia), and thyroid gland(hypothyroidism, goiter). Furthermore, chronic ingestion of iodides (in animals)during pregnancy has resulted in fetal deaths, severe goiter and cretinoidappearance of the newborn. Prolonged or repeated skin contact may causeallergic reaction.

Sensitization: May cause sensitization by skin contact.

Mutagenic Effects: May affect genetic material based on animal test dataNo human data found

Carcinogenic effects: Not considered carcinogenic.

Components CAS-No. IARC ACGIH -Carcinogens

NTP OSHA HCS -Carcinogens

Australia -Notifiable

CarcinogenicSubstances

Australia -Prohibited

CarcinogenicSubstances

Potassium Iodide 7681-11-0 Not listed A4 - NotClassifiable asa HumanCarcinogen(listed asIodides)

Not listed Not listed Not listed Not listed

ACGIH (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 Suspected of damaging fertility or the unborn child

Reproductive Effects: No information availableDevelopmental Effects: No information availableTeratogenic Effects: No information available

Specific Target Organ Toxicity

STOT - single exposure Respiratory system.STOT - repeated exposure Causes damage to organs through prolonged or repeated exposure.Target Organs: Thyroid.

12. ECOLOGICAL INFORMATION

Ecotoxicity


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Ecotoxicity effects: No data available.

Persistence and degradability: No information available

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

Potassium Iodide 7681-11-0 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 Regulated


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Proper 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 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.

Potassium Iodide 7681-11-0 PresentACTIVE

PresentKE-29149

Present Present(1)-439

Present Present Present231-659-4

U.S. Regulations

Potassium IodideFDA - Food Additives Generally Recognized as Safe (GRAS): 21 CFR 184.1634

FDA - Direct Food Additives 21 CFR 172.375FDA - 21 CFR - Total Food Additives 100.155, 172.375, 178.1010, 184.1634, 582.80

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:

Potassium Iodide 7681-11-0 Not Listed Not Listed Not Listed Not Listed

CERCLA/SARA

Components CAS-No. CERCLA - Section 302 Section 302 Section 313 - Section 313 -


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HazardousSubstances andtheir Reportable

Quantities

ExtremelyHazardousSubstancesand TPQs

ExtremelyHazardous

Substances andRQs

Chemical Category Reporting de minimis

Potassium Iodide 7681-11-0 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

Potassium Iodide 7681-11-0 Not Applicable Not Applicable

Canada

WHIMIS 2015 - GHS Classifications

WHMIS 2015 Hazard ClassificationInformation:

.

Component WHMIS 2015 Hazard ClassificationPotassium Iodide 7681-11-0 ( 100 )

Specific target organ toxicity - Repeated exposure - Category 1:H372 Causes damage to organs through prolonged or repeatedexposure.

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 ClassD2A Very toxic materials

Components WHMIS 1988Potassium Iodide D2A

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.

Components WHMIS Ingredient Disclosure List -Potassium Iodide 1 %

Inventory

Components CAS-No. Canada (DSL) Canada (NDSL)Potassium Iodide 7681-11-0 Present Not Listed

Components CAS-No. CEPA Schedule I - Toxic SubstancesPotassium Iodide 7681-11-0 Not listedComponents CAS-No. CEPA - 2010 Greenhouse Gases Subject

to Mandatory ReportingPotassium Iodide 7681-11-0 Not listed

EU Classification

EU GHS - SV - CLP 1272/2008

Components CAS-No. EU GHS - SV - CLP (1272/2008)Potassium Iodide 7681-11-0 No information

EU - CLP (1272/2008)


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R-phrase(s)Not determined

none

S -phrase(s)none

Components CAS-No. Classification ConcentrationLimits:

Safety Phrases

Potassium Iodide 7681-11-0 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: 01/22/2015Revision Date: 08/06/2018Prepared by: Sonia Owen

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


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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

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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 [email protected] if I may be of further assistance. Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance

mailto:[email protected]

July 26, 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 PO185 Potassium Iodide, 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

mailto:[email protected]

April 13, 2016 Re: Potassium Iodide, USP- PO185 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 Potassium Iodide, USP- PO185 is BSE/TSE free. If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag- Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

April 13, 2016 Re: Potassium Iodide, USP-PO185 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 (Dairy products; Egg products, Corn products; Wheat products, Rye products; Barley products; Rice products; Oat products; Soy products., Sunflower products; Safflower products; Celery; Mustards; Sesame seeds; Lupine; Nut products; Peanut products; Chocolate/Chocolate derivatives; Monosodium Glutamate; Sulfur Dioxide; Hydrolyzed proteins; Autolyzed Yeast or Yeast extracts; Sulfites; BHA, BHT, Tocopherols or TBHQ; Beef products or their derivatives; Pork products or their derivatives; Fish/Shellfish products or any other plant or animal byproducts, and Cereals containing Gluten) Potassium Iodide, USP-PO185

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

April 14, 2016 Re: Potassium Iodide, USP- PO185 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, the product listed below is not contaminated with Aflatoxins. Aflatoxins are not used in production. The following product does not come in contact with Aflatoxins at any stage of production. Potassium Iodide, USP- PO185 If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

Certificate Of Analysis

Item Number PO185 Lot Number 1IA0559

Item Potassium Iodide, USP Manufacturer Lot 827001

CAS Number 7681-11-0 Manufacturer Code 46

Molecular Formula KI Molecular Weight 166.00

Test Specification Resultmin max

99.0 101.5 % 99.7 %

NO COLOR ISPRODUCED

NO COLOR ISPRODUCED

1.0 % 0.1 %

4 μg/g

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 Elemental Impurities – Limits and 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.

Certificate Of Analysis

Item Number PO185 Lot Number 2IA0108

Item Potassium Iodide, USP Manufacturer Lot 825302

CAS Number 7681-11-0 Manufacturer Code 46

Molecular Formula KI Molecular Weight 166.00

Test Specification Resultmin max

99.0 101.5 % 99.9 %

NO COLOR ISPRODUCED

NO COLOR ISPRODUCED

1.0 % 0.1 %

4 μg/g

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 Elemental Impurities – Limits and 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.

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

Chemical Emergency: (800)424-9300*49452PO185062233BOA* PO185 2.5 KG

Potassium IodideU.S.P.

CAS 7681-11-0

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

WARNING• Causes eye irritation • May cause respiratory irritation • May cause an allergic skin reaction • Suspected of damaging fertility or the unborn child. • Obtain special instructions before use • Do not handle until all safety precautions have been read and understood • Wear protective gloves, protective clothing, eye protection, face protection • Avoid breathing dust • Use only outdoors or in a well-ventilated area • Wash face, hands and any exposed skin thoroughly after handling • Contaminated clothing should not be allowed out of the workplace.FIRST AID: Call a POISON CENTER of physician if you feel unwell. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention. IF ON SKIN: Wash with plenty of water. Wash contaminated clothing before reuse. If skin irritation or rash occurs: Get medical attention. IF INHALED: Remove person to fresh air and keep comfortable for breathing.

KEEP FROM CHILDRENG 14/E1GHS A Lot No. 062233

KI F.W. 166.00Assay .............................................. 99.0-101.5%Alkalinity ...........................................To pass test

MAXIMUM LIMITSLoss on Drying ............................................ 1.0%Iodate .................................................... 0.0004%Nitrate, Nitrite and Ammonia .............To pass testThiosulfate, Barium ...........................To pass testHeavy Metals ........................................... 0.001%Residual Solvents .............................To pass testWARNING: 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.LIGHT SENSITIVE, MOISTURE SENSITIVE: Keep tightly closed in light-resistant containers.

www.SpectrumChemical.com

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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

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Toll-Free 24-Hour Chemical Emergency Telephone Number

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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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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

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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 [email protected] if we may be of further assistance.

Sincerely,

Howard Lau, Quality Assurance Specialist

26.July.2019

Stability – Shelf Life Guidance Product Covered: PO185, Potassium Iodide, USP Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, PO185, Potassium Iodide, 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

Document id:

The following product(s) prepared by the named company are certied kosher with the stated requirements:

This certicate expires on

Placing the KSA logo on products not listed above constitutes an un-authorized use of the KSA symbol, which is a federally registered trademark.

Rabbi Binyomin LisbonKashrus Administrator

P.O.Box 35721, Los Angeles, Ca 90035 - (310) 282-0444 - Fax (310) 282-0505 - Email [email protected] - www.ksakosher.com

בס’’ד

Product Name

Brand

UKD-ID

D/P/M

Symbol Required

Special Conditions

S-0032

Spectrum Laboratory Products, Inc.

Feb 04, 2019

PO185, Potassium Iodide, USP

Spectrum

KSAV3-Q7L2N58

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KSA

Feb 01, 2020

-1083681

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14422 S. San Pedro StreetGardena, CA 90248

USA

ProductName Product Code Halal-ID Product Certificate #

1. Potassium Iodide, USP PO185 B94034 HC-19SP1X66

This is to certify that the following product(s) have been produced under the supervision of the Islamic Food and Nutrition Council of America(IFANCA).The production facility as well as component ingredients have been reviewed and approved. The product(s) are in compliance with the halal requirements underIslamic laws.

Date: June 18, 2019

Document #: 11205.11209.II191058

Company Name & Address: Spectrum Laboratory Products, Inc. 755-769 Jersey Ave New Brunswick, New Jersey 08901 USA

Plant Name & Address: Spectrum Laboratory Products, Inc. 14422 South San Pedro Street Gardena, California 90248 USA

Muhammad Munir Chaudry, Ph.D.President

This Certificate is valid until August 31, 2020 and subject to renewal at that time.

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