M1447, Methenamine, USP

Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package.

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

Ver4.04 25.July.2019

Scientific Documentation M1447, Methenamine, 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]

25.July.2019

M1447, Methenamine, 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 Methenamine, USP (M1447)

Item Number M1447

Item Methenamine, USP

CAS Number 100-97-0

Molecular Formula C6H12N4

Molecular Weight 140.19

MDL Number

Synonyms Hexamethylenetetramine ; Methenamine ; Hexamine

Test SpecificationMin Max

ASSAY (DRIED BASIS) 99.0 100.5%

LOSS ON DRYING 2.0%

RESIDUE ON IGNITION 0.1%

CHLORIDE (Cl) 0.014 %

SULFATE TO PASS TEST

AMMONIUM SALTS TO PASS TEST

ELEMENTAL IMPURITIES AS REPORTED

IDENTIFICATION TO PASS TEST

EXPIRATION DATE

DATE OF MANUFACTURE

APPEARANCE

RESIDUAL SOLVENTS TO PASS TEST

https://www.spectrumchemical.com

https://www.spectrumchemical.com/OA_HTML/chemical-products_Methenamine-USP_M1447.jsp?minisite=10020&respid=22372

https://www.spectrumchemical.com/OA_HTML/chemical-products_Methenamine-USP_M1447.jsp?minisite=10020&respid=22372

https://www.spectrumchemical.com/OA_HTML/chemical-cas_Methenamine-USP_100-97-0.jsp?pCasName=Methenamine-USP

SAFETY DATA SHEETPreparation Date: 05/27/2015 Revision Date: 06/22/2018 Revision Number: G2

1. IDENTIFICATIONProduct identifier

Product code: M1447Product Name: METHENAMINE, USP

Other means of identification Synonyms: 1,3,5,7-Tetraazaadamantane

1,3,5,7-Tetraazatricyclo (3.3.1.1(3,7))decane1,3,5,7-Tetraazatricyclo(3.3.1.1(sup 3,7))decane1,3,5,7-Tetraazatricyclo(3.3.1.1(sup 37))decaneAminoformaldehydeAmmonioformaldehydeEsametilentetramina [Italian]FormamineForminHeterinHexaformHexamethylenamineHexamethyleneamineHexamethylenetetraamineHexamethylenetetramineHexamethylenetetraminumHexamethylentetramin [German]HexamethylentetramineHexamethylentetraminumHexamineHexaminumHexasanHexilmethylenamineMetenamina [INN-Spanish]MethenaminMethenamineMetramineUraminUratrineUritoneUrodeineUrotropinUrotropineXametrin

CAS #: 100-97-0RTECS # MN4725000CI#: Not available

Recommended use of the chemical and restrictions on use Recommended use: No information available.Uses advised against No information available

Product code: M1447 Product name: METHENAMINE, USP 1 / 13

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 2BRespiratory sensitization Category 1Skin sensitization Category 1

Label elements

Hazards not otherwise classified (HNOC) Not Applicable

Other hazards May be harmful if inhaledCauses mild skin irritation

Precautionary Statements - PreventionWash face, hands and any exposed skin thoroughly after handlingAvoid breathing dust/fume/gas/mist/vapors/sprayIn case of inadequate ventilation wear respiratory protectionContaminated work clothing must not be allowed out of the workplaceKeep away from heat/sparks/open flames/hot surfaces. — No smokingGround/bond container and receiving equipmentUse explosion-proof electrical/ventilating/lighting/.../equipmentWear protective gloves/protective clothing/eye protection/face protection

Precautionary Statements - Response

In case of fire: Use CO2, dry chemical, or foam to extinguish.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If

Flammable solids Category 2

Danger

Hazard statementsMay cause an allergic skin reactionMay cause allergy or asthma symptoms or breathing difficulties if inhaledCauses eye irritationFlammable solids


eye 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: If breathing is difficult, remove person to fresh air and keep comfortable for breathing. If experiencing respiratorysymptoms: Call a POISON CENTER or doctor/physician.

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

3. COMPOSITION/INFORMATION ON INGREDIENTS

Components CAS-No. Weight %Methenamine 100-97-0 100

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.

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 Causes eye irritationMild skin irritationMay cause allergy or asthma symptoms or breathing difficulties if inhaledCoughing and wheezingDyspnea (Shortness of breath and difficulty breathing)May cause abdominal pain, nausea, vomiting, diarrhea

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. Foam.

Unsuitable Extinguishing Media: Do not use a solid (straight) water stream as it may scatterand spread fire.


Specific hazards arising from the chemical

Hazardous Combustion Products: Carbon Monoxide, Carbon Dioxide. Nitrogen Oxides.

Specific hazards: Flammable solid. May be ignited by heat, sparks or flames.Container explosion may occur under fire conditions orwhen heated. Fire may produce irritating and/or toxicgases.

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

7. HANDLING AND STORAGE

Precautions for safe handling

Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Keep away from incompatible materials. Remove allsources of ignition. To avoid ignition of vapors by static electricity discharge, all metal parts of the equipment mustbe grounded.

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

Conditions for safe storage, including any incompatibilities

Technical Measures/Storage Conditions:Hygroscopic. Do not store above 25°C/77°F. Keep container tightly closed in a dry and well-ventilated place. Keepaway from heat and sources of ignition. Store in a segregated and approved area. Store away from incompatiblematerials.

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. Use personal protective equipment. Do not touchdamaged containers or spilled material unless wearing appropriate protective clothing.Remove all sources of ignition. All equipment used when handling the product must begrounded. Take precautionary measures against static discharges. Use spark-proof toolsand explosion-proof equipment.

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 Use appropriate tools to put the spilled solid in a suitable waste disposal container.Use only non-sparking tools. Clean contaminated surface thoroughly.


Incompatible Materials:Oxidizing agentsSodium PeroxideIodine1-bromopentaboraneIodoformHydrochloric acid solutionSulfuric acidNitric acidMetalsAluminumZincSodium hydroxidePotassium hydroxide

8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters

National occupational exposure limits

United States

Components CAS-No. OSHA NIOSH ACGIH AIHA WEELMethenamine 100-97-0 None None None None

Canada

Components CAS-No. Canada - Alberta Canada - BritishColumbia

Canada - Ontario Canada - Quebec

Methenamine 100-97-0 None None 0.35 ppm STEL2 mg/m3 STEL

None

Australia and Mexico

Components CAS-No. Australia MexicoMethenamine 100-97-0 None None

Appropriate engineering controls

Engineering measures to reduce exposure: Use process enclosures, local exhaust ventilation, or otherengineering controls to keep airborne levels belowrecommended exposure limits. If user operationsgenerate dust, fume or mist, use ventilation to keepexposure to airborne contaminants below the exposurelimit.

Individual protection measures, such as personal protective equipment

Personal Protective Equipment

Eye protection: Goggles

Skin and body protection: Chemical resistant apronLong sleeved clothingGloves

Respiratory protection: Wear respirator with dust filter. Be sure to use an approved/certified respirator orequivalent.


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

10. STABILITY AND REACTIVITYReactivity Explosive reaction with acetic acid + acetic anhydride + ammonium nitrate + nitric acidReactive with oxidizing agentsReacts violently with sodium peroxide, 1-bromopentaborane, iodine, iodoform. Incompatible with metals (aluminum and zinc) andstrong bases (sodium hydroxide and potassium hydroxide)

Chemical stability

Stability: Hygroscopic. Stable under recommended storage conditions.

Possibility of Hazardous Reactions: Hazardous polymerization does not occur

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

Incompatible Materials: Oxidizing agentsSodium PeroxideIodine1-bromopentaborane

Physical state:Solid

Appearance:Crystalline powder.

Color:Colorless. White.

Odor:Odorless.

TasteNo information available.

Formula:C6H12N4

Molecular/Formula weight:140.19

Flammability:Flammable solid

Flashpoint (°C/°F):250°C/ 482°F

Flash Point Tested according to:Closed cup

Autoignition Temperature (°C/°F):> 371°C/ > 700°F

Lower Explosion Limit (%):No information available

Upper Explosion Limit (%):No information available

Melting point/range(°C/°F):263-280°C/ 505.4-536°F

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

Boiling point/range(°C/°F):No information available

Bulk density:No information available

Density (g/cm3):No information available

Specific gravity:1.33

pH:No information available

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

Evaporation rate:No information available

Vapor density:4.9

VOC content (g/L):No information available

Odor threshold (ppm):No information available

Partition coefficient(n-octanol/water):-2.84

Viscosity:No information available

Miscibility:No information available

Solubility:Soluble in cold waterInsoluble in diethyl etherInsoluble in ChloroformInsoluble in AlcoholSoluble in Ethanol


IodoformHydrochloric acid solutionSulfuric acidNitric acidMetalsAluminumZincSodium hydroxidePotassium hydroxide

Hazardous decomposition products:

Carbon oxides. Nitrogen oxides (NOx).

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:Inhalation. Ingestion.

Acute Toxicity

Component Information

MethenamineCAS-No. 100-97-0

LD50/oral/rat = > 20000 mg/kg Oral LD50 RatLD50/oral/mouse = 569 mg/kgLD50/dermal/rabbit = No information availableLD50/dermal/rat = > 2000 mg/kg Dermal LD50LC50/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 = 9200 mg/kg

LD50/oral/mouse =Value - Acute Tox Oral = 569 mg/kg

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

LD50/dermal/ratVALUE -Acute Tox Dermal = >2000 mg/kg

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


VALUE-Dust/Mist = No information available

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

Symptoms

Skin Contact: Mild skin irritation.

Eye Contact: Mild eye irritation.

Inhalation Causes respiratory tract (nose, throat, lungs), and mucous membrane irritation. Itmay affect the urinary system. May affect metabolism.

Ingestion Causes gastrointestinal tract irritation/distress with anorexia, nausea, abdominalpain/cramps, vomiting and diarrhea. May affect the urniary system (bladder,kidneys-dysuria), behavior/central nervous system (headache, excitement, musclecontraction, spasticity, tremor). May affect respiration (dyspnea). May causemuscle cramps.

Aspiration hazard No information available.

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

Chronic Toxicity Skin: Sensitizer. May cause allergic skin reaction (allergic contact dermatitis).Inhalation: May cause allergic respiratory reaction (occupational asthma).

Sensitization: May cause sensitization by inhalation. May cause sensitization by skin contact.

Mutagenic Effects: May affect genetic materialExperiments with bacteria and/or yeast have shown mutagenic effects

Carcinogenic effects: Not considered carcinogenic.

Components CAS-No. IARC ACGIH -Carcinogens

NTP OSHA HCS -Carcinogens

Australia -Notifiable

CarcinogenicSubstances

Australia -Prohibited

CarcinogenicSubstances

Methenamine 100-97-0 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: Aquatic environment.

Methenamine - 100-97-0Freshwater Fish Species Data: 44600 - 55600 mg/L LC50 Pimephales promelas 96 h flow-through 1Water Flea Data: 29868 - 43390 mg/L EC50 Daphnia magna 48 h

Persistence and degradability: 22% (by BOD), 48% (by HPLC), 45% (by TOC)

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

Methenamine 100-97-0 None None None None

14. TRANSPORT INFORMATION

DOTUN-No: UN1328Proper Shipping Name: HexamethylenetetramineHazard Class: 4.1Subsidiary Class No information availablePacking group: IIIEmergency Response GuideNumber

133

Marine Pollutant No data availableDOT RQ (lbs): No information availableSpecial Provisions A1, IB8, IP3, T1, TP33Symbol(s): No information availableDescription: UN1328, Hexamethylenetetramine, 4.1, III

TDG (Canada)UN-No: UN1328Proper Shipping Name: HexamethylenetetramineHazard Class: 4.1Subsidiary Risk: No information availablePacking Group: IIIMarine Pollutant No Information availableDescription: UN1328, Hexamethylenetetramine, 4.1, III

ADRUN-No: UN1328Proper Shipping Name: Hexamethylene-tetramine


Hazard Class: 4.1Packing Group: IIISubsidiary Risk: No information availableDescription: UN1328, Hexamethylene-tetramine, 4.1, III

IMO / IMDGUN-No: UN1328Proper Shipping Name: HexamethylenetetramineHazard Class: 4.1Subsidiary Risk: No information availablePacking Group: IIIMarine Pollutant No information availableEMS: F-ADescription UN1328, Hexamethylenetetramine, 4.1, III

RIDUN-No: UN1328Proper Shipping Name: HexamethylenetetramineHazard Class: 4.1Subsidiary Risk: No information availablePacking Group: IIIDescription: UN1328, Hexamethylenetetramine, 4.1, III

ICAOUN-No: UN1328Proper Shipping Name: HexamethylenetetramineHazard Class: 4.1Subsidiary Risk: No information availablePacking Group: IIIDescription: UN1328, Hexamethylenetetramine, 4.1, III

IATAUN-No: UN1328Proper Shipping Name: HexamethylenetetramineHazard Class: 4.1Subsidiary Risk: No information availablePacking Group: IIIERG Code: 3LSpecial Provisions No information availableDescription: UN1328, Hexamethylenetetramine, 4.1, III

15. REGULATORY INFORMATION

International Inventories

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

Japan ENCS CHINA Australia(AICS)

EINECS-No.

Methenamine 100-97-0 PresentACTIVE

PresentKE-18615

Present Present(5)-1155

Present Present Present202-905-8

U.S. Regulations

MethenamineNew Jersey RTK Hazardous Substance List: 0996

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:

Methenamine 100-97-0 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

Methenamine 100-97-0 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

Methenamine 100-97-0 Not Applicable Not Applicable

Canada

WHIMIS 2015 - GHS Classifications

WHMIS 2015 Hazard ClassificationInformation:

.

Component WHMIS 2015 Hazard ClassificationMethenamine 100-97-0 ( 100 )

Flammable solids - Category 2: H228 Flammable solid.;Respiratory sensitizers - Category 1: H334 May cause allergic orasthmatic symptoms or breathing difficulties if inhaled.; Skinsensitizers - Category 1B: H317 May cause allergic skin reaction.;Combustible Dust - Category 1: May form combustible dustconcentrations in air (if 5% or more by weight of its compositionhas a particle size <500 µm)

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 ClassB4 Flammable solid

Components WHMIS 1988Methenamine B4

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 -Methenamine 0.1 %

Inventory

Components CAS-No. Canada (DSL) Canada (NDSL)Methenamine 100-97-0 Present Not Listed

Components CAS-No. CEPA Schedule I - Toxic SubstancesMethenamine 100-97-0 Not listedComponents CAS-No. CEPA - 2010 Greenhouse Gases Subject

to Mandatory Reporting


Methenamine 100-97-0 Not listed

EU Classification

EU GHS - SV - CLP 1272/2008

Components CAS-No. EU GHS - SV - CLP (1272/2008)Methenamine 100-97-0 Flammable solids - Flam. Sol. 2: H228

Flammable solid.; Skin sensitizers -Skin Sens. 1: H317 May cause allergic

skin reaction.612-101-00-2

EU - CLP (1272/2008)

R-phrase(s)R11 - Highly flammable.R43 - May cause sensitization by skin contact.

S -phrase(s)S 2 - Keep out of the reach of children.S24 - Avoid contact with skin.S37 - Wear suitable gloves.

Components CAS-No. Classification ConcentrationLimits:

Safety Phrases

Methenamine 100-97-0 F; R11R43

No information S: (2)-24-37

The product is classified in accordance with Annex VI to Directive 67/548/EEC

Indication of danger:F - Highly flammable.Xi - Irritant.

16. OTHER INFORMATION

Preparation Date: 05/27/2015Revision Date: 06/22/2018Prepared 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 personal


protection 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


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

Methenamine, USP - M1447

Condensation Concentration

Dissolution Crude productDecolorization

Concentration

Formaldehyde Ammonia

Crystallization

Filtering

Drying

Final product

Carbon

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

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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

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 M1447 Methenamine, 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 14, 2016 Re: Methenamine, USP- M1447 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 Methenamine, USP- M1447 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 15, 2016 Re: Methenamine, USP-M1447 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, Tree Nut, Wheat, Peanut, Soy, Cereals containing Gluten, Celery and Sesame Seed). Methenamine, USP-M1447

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 15, 2016 Re: Methenamine, USP- M1447 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. Methenamine, USP- M1447 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 M1447 Lot Number 2IH0045

Item Methenamine, USP Manufacturer Lot H20190402

CAS Number 100-97-0 Manufacturer Code 3771

Molecular Formula C6H12N4 Molecular Weight 140.19

Test Specification Resultmin max

99.0 100.5% 99.73 %

2.0% 0.72 %

0.1% <0.1 %

0.014 % <0.014 %

TO PASS TEST PASSES TEST


AS REPORTEDNO ELEMENTAL

IMPURITIESPRESENT


30-APR-2022

01-APR-2019

WHITE CRYSTALS

TO PASS TEST NO RESIDUALSOLVENTS USED


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.

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.

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

Chemical Emergency: (800)424-9300*49452M1447062233LVA* M1447 12 KG

Methenamine(Hexamethylenetetramine;

Hexamine)U.S.P.

CAS 100-97-0CAUTION: For manufacturing, processing, repacking, or for prescription compounding. Rx only.Read and understand the label and Safety Data Sheet (SDS) prior to use.

DANGER• Flammable solid • May cause an allergic skin reaction • May cause allergy or asthma symptoms or breathing difficulties if inhaled • Causes eye irritation • Causes mild skin irritation.• Keep away from heat, sparks, open flames, hot surfaces • No smoking • Ground container and receiving equipment • Use explosion-proof equipment • Do not eat, drink or smoke when using this product • Wear respiratory protection, eye protection, face protection, protective gloves • Do not breathe dust • Wash face, hands and any exposed skin thoroughly after handling • Contaminated work clothing must not be allowed out of the workplace.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. If on skin: Wash with plenty of water. Wash contaminated clothing before reuse. If skin irritation or rash occurs: Get medical attention. IF INHALED: If breathing is difficult, remove person to fresh air and keep comfortable for breathing. If experiencing respiratory symptoms: Call a poison center or physician.IN CASE OF FIRE: Use an approved dry powder, alcohol-resistant foam, CO2 or water spray to extinguish.

KEEP FROM CHILDRENR 4/E1GHS A Lot No. 062233

C6H12N4 F.W. 140.19Assay (Dried Basis) ......................... 99.0-100.5%

MAXIMUM LIMITSLoss on Drying ............................................ 2.0%Residue on Ignition ..................................... 0.1%Chloride .................................................. 0.014%Sulfate ...............................................To pass testAmmonium Salts ..............................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.HYGROSCOPIC: Keep tightly closed. Store below 25°C.

www.SpectrumChemical.com

Exp.

Dat

e: 0

3-31

-202

5

DOT: UN1328, Hexamethylenetetramine, 4.1, PG III

SsXxFf

Empirical Formula, Formula Weight and Technical Specifications Panel

Expiration Information

Lot Number

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

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K

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A

I

C

H

F

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L

E

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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.

N

Label Legend

M

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.

G

D

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Corporate Headquarters: West Coast Facility:

769 Jersey Ave. 14422 S. San Pedro St.

New Brunswick, NJ 08901 Gardena, CA 90248

732.214.1300 310.516.8000

Label Information

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

769 Jersey Avenue

New Brunswick, NJ 08901

PHONE 732.214.1300

FAX 732.246.7132

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

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

14422 South San Pedro Street

Gardena, California 90248

PHONE 310.516.8000

FAX 310.516.9843

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

February 1, 2019 RE: Lot Numbering System Dear Valued Customer: This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production. The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned. Example: ZI0928 = The 928th material produced in California in September 2010 The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility: 1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility 4 = Pharmacy, NJ Facility The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned. Example: 2AA0706 = The 706th material produced in New Jersey in January 2011 Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance.

Sincerely,

Howard Lau, Quality Assurance Specialist

25.July.2019

Stability – Shelf Life Guidance

Product Covered: M1447, Methenamine, USP

Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above.

The product, M1447, Methenamine, 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

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Documents

M1447, Methenamine, USP