300 Northfield Road
MATERIAL SAFETY DATA SHEET
Bedford, OH 44146
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Ranitidine Injection 25 mg/mL; 2,6, and 40 mL vials.
Chemical Names: N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2- nitro-
1,1-ethenediamine, phosphate
Synonyms: Zantac?br>
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: 1(800)424-9300
Telephone Number for Info.: (800)562-4797 or (440)232-3320
Medical Emergency: Professional Services: 1(800)521-5169
Date Prepared: March 20, 2006
Date Revised: July 20, 2007
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
250 ug/m3
Ranitidine 2.5 66357-35-5 NONE NONE
(BVL OEL)
Phenol 0.5 108-95-2 5 ppm 5 ppm NONE
Monobasic Potassium Phophate 0.096 7778-77-0 NONE NONE NONE
Dibasic Sodium Phosphate 0.24 7758-11-4 NONE NONE NONE
Water for Injection 96.66 7732-18-5 NONE NONE NONE
Hydrochloric Acid is added for pH adjustment.
Ranitidine is a sterile injectable liquid drug provided in 2 and 6 mL vials.
Section III - HEALTH HAZARD DATA
Routes of Entry: Ranitidine Injection may be absorbed via contact with skin or eyes; inhalation of
aerosols or accidentally ingested. Under normal use with supervision of a physician, Ranitidine
Injection presents little hazard.
Health Hazard (Acute & Chronic): Ranitidine is used as an anti-ulcer agent. Ranitidine may affect the
digestive tract, eyes, skin, and respiratory tract. Minimal health hazard is expected upon
occupational exposure. Product may cause allergic reactions in susceptible individuals.
Ranitidine has low chronic toxicity.
Carcinogenicity: NTP? NO IARC Monographs? NO OSHA Regulated? NO
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Signs & Symptoms of Exposure: Acute signs and symptoms of exposure may include eye, skin, and
respiratory irritation, nausea, headache, dizziness, fatigue, constipation, abdominal pain or skin rash.
Medical Conditions Generally Aggravated by Exposure: Persons sensitive to Ranitidine may experience
allergic reaction.
BVL Hazard Category: 2
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BVL Occupational Exposure limit (OEL): 250 ug/m
Section IV - FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 minutes or more. Seek treatment from
a physician.
Skin Exposure: Wash skin with cool, soapy water. Remove contaminated clothing.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately.
Inhalation: If difficulty breathing, administer oxygen. Seek medical attention immediately.
If necessary, provide artificial respiration. Overdose should be treated symptomatically.
Section V - FIRE AND EXPLOSION HAZARD DATA
Flash Point (Method Used): Not applicable LEL: Not Applicable UEL: Not Applicable
Flammable Limits: Not applicable
Extinguishing Media: Use water or multi-purpose ABC extinguisher
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire fighters
must wear self-contained breathing apparatus to avoid inhalation of smoke. Product is aqueous-
based and is not expected to present a fire hazard concern.
Unusual Fire/Explosion Hazards: None
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Absorb Ranitidine with absorbent wipes/towels. Prevent contact with sewers and
waterways. Wash area with soap and water. Wear personal protective equipment.
Release to Air: If aerosols are generated, reduce exposures by ventilating and preventing the
generation of aerosols. Wear respiratory protection.
Release to Water: Refer to the local water authority; drain disposal is not recommended. Refer to
local, state, and federal guidelines.
Section VII - PRECAUTIONS FOR SAFE HANDLING AND USE
Steps to be taken in case material is released or spilled: See Section VI above. Wear all necessary
protective equipment including nitrile or latex gloves, protective clothing, safety glasses, and an
air-purifying respirator with HEPA (P100) cartridges. Large spills may require the use of
protective coveralls, boots, double gloves and SCBAs.
Waste Disposal Method: Dispose of according to local, state, and federal guidelines. Incineration at
a licensed facility is recommended.
Precautions to be taken in handling and storing: Store at room temperature (15-25癈).
Other Precautions: None identified.
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Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Under normal use, respirators should not be required if adequate ventilation is
available. If aerosol generation is likely, air-purifying respirators with HEPA cartridge (P100)
must be worn. For large spill emergencies, self-contained breathing apparatus (SCBA) may be
required. Personnel wearing respirators should be fit tested and approved for respirator use under
the OSHA Respiratory Protection Standard, 29 CFR 1910.134.
Ventilation: Handle product in a well-ventilated area.
Protective Gloves: Nitrile or latex
Eye Protection: Safety glasses or goggles
Other Protective Clothing or Equipment: Lab coat
Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking when
handling this product.
Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS
Physical State: Liquid Specific Gravity: Approximate to water
Appearance and Odor: Clear, colorless to yellow, odorless Melting Point: Not applicable
Boiling Point: Approximate to water Evaporation Rate: Approximate to water
Vapor Pressure: Approximate to water Solubility in Water: Soluble
Vapor Density: Approximate to water pH: 6.9 ?7.1
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid):
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include
potentially hazardous byproducts of nitrogen oxides, carbon monoxide, carbon dioxide, and oxides
of sulfur.
Hazardous Polymerization: Will not occur.
Conditions to Avoid: None identified.
Section XI - TOXICOLOGICAL INFORMATION
For Ranitidine: RTECS # KM6556500
LD50 oral, rat > 5 gm/kg LD50 oral, mouse = 884 mg/kg
LD50 intravenous, rat = 93 mg/kg LD50 intravenous, mouse = 80 mg/kg
LD50 intramuscular, rat = 2018 mg/kg LD50 intramuscular, mouse = 280 mg/kg
Additional toxicity data is available from the National Institute for Occupational Safety and Health
(NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS).
Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Ranitidine. Handle in a manner that
prevents spills or releases to the environment.
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Section XIII - DISPOSAL INFORMATION
Ranitidine should be disposed of in accordance with national, state, local, or applicable regulations.
Incineration at an approved, permitted facility is recommended.
Section XIV - TRANSPORTATION INFORMATION
Ranitidine 25 mg/mL is not a DOT Hazardous Material.
Ranitidine is not a Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: No
CERCLA listed?: No
RCRA listed?: No
TSCA listed: No
Section XVI - OTHER DATA
1. Use of this product should be through or under the direction of a physician.
This MSDS does not address the therapeutic use of this material
2. Persons administering this drug to patients must be careful to avoid needle sticks to syringes and
other sharps used in the administration. All needle sticks must be reported to your company
Management.
3. BVL Hazard Category Definitions (internal hazard ranking used by Ben Venue Laboratories):
1 = Low Toxicity
2.= Moderate Toxicity
3 = Potent or Toxic
4 = Highly Potent or Toxic
5 = Extremely Potent or Toxic
4. OEL=Occupational Exposure Limit. An internal limit set by Ben Venue Laboratories for the
recommended limit of employee exposure to airborne dusts or aerosols that should not be
exceeded over an eight-hour time-weighted average.
This document is generated to distribute health, safety and environmental data. It is not a specification sheet and none of the
displayed data should be construed as a specification. Information on this MSDS sheet was obtained from sources which we
believe are reliable, and we believe that the information is complete and accurate. However, the information is provided without
any warranty, express or implied, regarding its correctness. Some of the information presented and conclusions drawn are from
sources other than direct test data of the substance. The conditions or methods of handling, storage, use and disposal of the product
are beyond our control and may also be beyond our knowledge. It is the user's responsibility to determine the suitability of any
material for a specific purpose and to adopt such safety precautions as may be necessary. If the product is used as a component in
another product, this MSDS information may not be applicable. For these reasons, we do not assume any responsibility and
expressly disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling, storage, use
or disposal of this product.
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