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
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
Product code: M1447 Product name: METHENAMINE, USP 2 / 13
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.
Product code: M1447 Product name: METHENAMINE, USP 3 / 13
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.
Product code: M1447 Product name: METHENAMINE, USP 4 / 13
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.
Product code: M1447 Product name: METHENAMINE, USP 5 / 13
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
Product code: M1447 Product name: METHENAMINE, USP 6 / 13
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
Product code: M1447 Product name: METHENAMINE, USP 7 / 13
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.
Product code: M1447 Product name: METHENAMINE, USP 8 / 13
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
Product code: M1447 Product name: METHENAMINE, USP 9 / 13
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)
Product code: M1447 Product name: METHENAMINE, USP 10 / 13
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
Product code: M1447 Product name: METHENAMINE, USP 11 / 13
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
Product code: M1447 Product name: METHENAMINE, USP 12 / 13
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
Product code: M1447 Product name: METHENAMINE, USP 13 / 13
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
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January 08, 2019 Certification of Compliance with current Good Manufacturing Practices Dear Valued Customer: Spectrum Chemical Mfg Corp certifies that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively. Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824 Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at [email protected] if I may be of further assistance. Sincerely,
Michael Dang Director, Quality Systems & GMP Compliance
July 25, 2019
Certification of Compliance with current Good Manufacturing Practices
Dear Valued Customer:
Spectrum Chemical Mfg Corp certifies that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.
Catalog Number Product Name 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
TO PASS TEST PASSES TEST
AS REPORTEDNO ELEMENTAL
IMPURITIESPRESENT
TO PASS TEST PASSES TEST
30-APR-2022
01-APR-2019
WHITE CRYSTALS
TO PASS TEST NO RESIDUALSOLVENTS USED
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.
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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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
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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