NOREPINEPHERINE BITARTRATE, USP 100GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name Norepinephrine Bitartrate USP Supplier Information Letco Medical, LLC 1316 Commerce Drive NW Decatur, AL 35601 1 (800) 239-5288 +1 (734) 843-4693 IN CASE OF EMERGENCY: Chemtrec 1 (800) 424-9300 (24 hours) Product Synonym(s) Norepinephrine Bitartrate Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute toxicity, oral Category 2, Specif ic target organ toxicity, single exposure Category 1 (cardiovascular system, central nervous system) Signal Word Danger Hazard Statement(s) H300 Fatal if swallowed H370 Causes damage to organs Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P301+P310+P330 IF SWALLOWED Immediately call a POISON CENTER or doctor/physician. Rinse mouth. P307+P311 IF exposed Call a POISON CENTER or doctor/physician. P405 Store locked up. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified Not classif ied Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Norepinephrine Bitartrate Common Name Noradrenaline acid tartrate; Levarterenol bitartrate CAS Number 69815-49-2 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider f amiliar with workplace chemical exposures. In the United States, the national poison control center phone number is 1-800-222-1222. If person is not breathing, give artif icial respiration. If breathing is dif f icult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If Inhaled Move to fresh air. Call a physician if symptoms develop or persist. In Case of Skin Contact Rinse skin with water/shower. Get medical attention if irritation develops and persists. In Case of Eye Contact Rinse with water. Get medical attention if irritation develops and persists. If Swallowed Call a physician or poison control center immediately. Rinse mouth. Do not induce vomiting without advice from poison control center. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs. Do not use mouth-to-mouth method if victim ingested the substance. Induce artif icial respiration with the aid of a pocket mask equipped with a one-way valve or other proper respiratory medical device. Most Important Symptoms and Effects Central nervous system ef f ects. Cardiovascular ef f ects. Indication of immediate medical attention and special treatment needed: In the event of an overdose, supportive and symptomatic measures should be used. If blood pressure f ails to lower, a short-acting alpha adrenergic blocking agent may be administered. Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Use f ire-extinguishing media appropriate f or surrounding materials. Water. Foam. Dry chemical or CO2. Special Hazards Arising From the Substance/Mixture No unusual f ire or explosion hazards noted. Special PPE and/or Precautions for Firefighters Wear suitable protective equipment. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Ensure adequate ventilation. Avoid inhalation of dust from the spilled material. Wear appropriate personal protective equipment. Methods and Materials Used for Containment Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination Cleanup Procedures Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination Section 7: Handling and Storage Precautions for Safe Handling Avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surf aces with suitable detergent or solvent af ter use. Af ter removing gloves, wash hands and other exposed skin thoroughly. Use of a designated area is recommended f or handling of potent materials. Conditions for Safe Storage Store in tight container as def ined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Biological limit values No biological exposure limits noted f or the ingredient(s). Exposure guidelines No exposure standards allocated. Appropriate Engineering Controls Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally pref erred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the ef f ectiveness of engineering controls. Ef f ectiveness of engineering controls intended f or use with highly potent materials should be assessed by use of nontoxic surrogate materials. Avoid any open handling of this material, particularly f or grinding, crushing, weighing, or other dustgenerating or aerosol-generating procedures. Use a laboratory f ume hood, vented enclosure, glovebox, or other ef f ective containment. Handle in accordance with good industrial hygiene and saf ety practice. PPE - Eye/Face Protection Saf ety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is pref erred. Maintain eyewash f acilities in the work area. PPE - Skin Protection Chemically compatible gloves. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. To reduce the risk of contamination of skin and surf aces, wear two pairs of gloves. Remove the outer gloves af ter handling and cleanup of the material, and remove the inner gloves only af ter removing other personal protective equipment. PPE - Body Protection For handling of laboratory scale quantities, a disposable lab coat or isolation gown over street clothes is recommended. Where signif icant quantities are handled, work clothing and booties may be necessary to prevent takehome contamination. PPE - Respiratory Protection Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an ef f ective respirator program in place (applicable U.S. regulation OSHA 29 CFR 1910.134). Page 2 of 4 Section 9: Physical and Chemical Properties Appearance White or f aintly gray crystalline powder. Upper/Lower Flammability or Explosive Limits Not available. Odor Odorless. Vapor Pressure Not available. Odor Threshold Not available. Vapor Density Not available. pH Not available. Relative Density Not available. Melting Point/Freezing Point Melting point/freezing point 208.4 - 219.2 �F (98 - 104 �C) Solubility Freely soluble in water. Slightly soluble in alcohol; practically insoluble in chlorof orm and in ether. Initial Boiling Point and Boiling Range Not available. Flash Point Not available. Evaporation Rate Not available. Flammability (Solid, Gas) Not applicable. Partition Coefficient Not available. Auto-Ignition Temperature Not available. Decomposition Temperature Not available. Viscosity Not available. Section 10: Stability and Reactivity Reactivity No reactivity hazards known. Chemical Stability Stable at normal conditions. Possibility of Hazardous Reactions No dangerous reaction known under conditions of normal use. Conditions to Avoid None known. Incompatible Materials Iron salts. Alkalies. Oxidizing agents. Hazardous Decomposition Products NOx. Irritating and/or toxic f umes or gases. Emits toxic f umes under f ire conditions. Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Rat Oral 20 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation Due to lack of data the classif ication is not possible. Serious Eye Damage/Irritation Due to lack of data the classif ication is not possible. Respiratory or Skin Sensitazation Due to lack of data the classif ication is not possible. Germ Cell Mutagenicity Due to lack of data the classif ication is not possible. Data from germ cell mutagenicity tests were not f ound. Carcinogenicity IARC This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity ACGIH No data available. Carcinogenicity NTP This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity OSHA This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Reproductive Toxicity Due to lack of data the classif ication is not possible. Adequate and well-controlled pregnancy studies have not been done in humans or animals. Intravenous norepinephrine given late in pregnancy causes uterine contractions which may result in f etal asphyxia. Specific Target Organ Toxicity - Single Exposure Causes damage to organs (cardiovascular system, central nervous system). Specific Target Organ Toxicity - Repeated Exposure Due to lack of data the classif ication is not possible. Aspiration Hazard Based on available data, the classif ication criteria are not met. Page 3 of 4 Section 12: Ecological Information Toxicity No ecotoxicity data noted f or the ingredient(s). Persistence and Degradability No data is available on the degradability of this product. Bio-accumulative Potential Not available. Mobility in Soil Not available. Other Adverse Effects Not available. Section 13: Disposal Considerations Waste Treatment Methods Product Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria f or hazardous waste. Waste Treatment Methods Packaging Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a saf e manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site f or recycling or disposal. Since emptied containers may retain product residue, f ollow label warnings even af ter container is emptied Special Precautions Landfill or Incinerations No data available Other Information No data available Section 14: Transport Information UN Number UN2811 UN Proper Shipping Name Toxic solid, organic, n.o.s. (Norepinephrine Bitartrate) Transport Hazard Class(es) 6.1 Packaging Group II Environmental Hazards No data available Section 15: Regulatory Information US f ederal regulations CERCLA/SARA Hazardous Substances - Not applicable. One or more components are not listed on TSCA. Superf und Amendments and Reauthorization Act of 1986 (SARA) Hazard categories Immediate Hazard - Yes Delayed Hazard - No Fire Hazard - No Pressure Hazard - No Reactivity Hazard - No SARA 302 Extremely hazardous substance No SARA 311/312 Hazardous chemical No Other f ederal regulations Saf e Drinking Water Act (SDWA) Not regulated. Food and Drug Administration (FDA) Not regulated. US state regulations Calif ornia Saf e Drinking Water and Toxic Enf orcement Act of 1986 (Proposition 65): This material is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. International Inventories Country(s) or region Inventory name On inventory (yes/no)* Australia Australian Inventory of Chemical Substances (AICS) No Canada Domestic Substances List (DSL) No Canada Non-Domestic Substances List (NDSL) No Country(s) or region Inventory name On inventory (yes/no)* China Inventory of Existing Chemical Substances in China (IECSC) No Europe European Inventory of Existing Commercial Chemical No Substances (EINECS) Europe European List of Notif ied Chemical Substances (ELINCS) No Japan Inventory of Existing and New Chemical Substances (ENCS) No Korea Existing Chemicals List (ECL) No New Zealand New Zealand Inventory No Philippines Philippine Inventory of Chemicals and Chemical Substances No (PICCS) United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No *A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s) Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/03/2019 16:02 Disclaimer Letco Medical, LLC believes that the above information is correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. If the product is used as a component in another product, this information may not be applicable. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED ABOVE. Letco Medical shall not be held liable for any loss or damage resulting from handling, storage, use or from contact with the above product. Page 4 of 4
