SAFETY DATA SHEET

1. Identification
Product identifier Mefenamic Acid
Other means of identification
Catalog number 1379605
Chemical name Benzoic acid, 2-[(2,3-dimethylphenyl)amino]-
Recommended use Specified quality tests and assay use only.
Recommended restrictions Not for use as a drug. Not for administration to humans or animals.
Manufacturer/Importer/Supplier/Distributor information
Company name U. S. Pharmacopeia
Address 12601 Twinbrook Parkway
Rockville
MD
20852-1790
US
Telephone RS Technical Services 301-816-8129
Website www.usp.org
E-mail [email protected]
Emergency phone number CHEMTREC within US & 1-800-424-9300
Canada
CHEMTREC outside US & +1 703-527-3887
Canada

2. Hazard(s) identification
Physical hazards Not classified.
Health hazards Acute toxicity, oral Category 4
Reproductive toxicity Category 2
Specific target organ toxicity, repeated Category 1 (cardiovascular system,
exposure gastrointestinal tract)
OSHA hazard(s) Not classified.

Label elements

Signal word Danger

Hazard statement Harmful if swallowed. Suspected of damaging fertility or the unborn child. Causes damage to
organs (cardiovascular system, gastrointestinal tract) through prolonged or repeated exposure.
Precautionary statement
Prevention Obtain special instructions before use. Do not handle until all safety precautions have been read
and understood. Do not breathe dust. Wash thoroughly after handling. Do not eat, drink or smoke
when using this product. Wear protective gloves/protective clothing/eye protection/face protection.
Response Rinse mouth. If swallowed: Call a poison center/doctor/medical professional/ if you feel unwell. If
exposed or concerned: Get medical advice/attention.
Storage Store locked up.
Disposal Dispose of contents/container to an approved disposal site.
Hazard(s) not otherwise Not classified.
classified (HNOC)

3. Composition/information on ingredients
Substance
Hazardous components
Chemical name Common name and synonyms CAS number %
Mefenamic Acid 61-68-7 100

Material name: Mefenamic Acid USP SDS US

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4. First-aid measures
Inhalation If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing.
Call a physician if symptoms develop or persist.
Skin contact Rinse skin with water/shower. Get medical attention if irritation develops and persists.
Eye contact Rinse with water. Get medical attention if irritation develops and persists.
Ingestion Rinse mouth. If ingestion of a large amount does occur, call a poison control center immediately.
Most important Cardiovascular effects.
symptoms/effects, acute and
delayed
Indication of immediate Treatment of nonsteroidal anti-inflammatory drug overdose should be symptomatic and supportive
medical attention and special and may include the following: Induce vomiting (DO NOT use syrup of ipecac) or perform gastric
treatment needed lavage. Administer activated charcoal as a slurry. Antacids may relieve adverse gastrointestinal
effects. Nephritis or nephrotic syndrome, thrombocytopenia, hemolytic anemia, severe cutaneous,
or other hypersensitivity reactions may respond to glucocorticoid administration. Administer as
required: plasma volume expanders for severe hypotension; diazepam or other benzodiazepine
for convulsions; vitamin K1 for hypoprothrombinemia; and/or dopamine plus dobutamine
intravenously to prevent or reverse early indications of renal failure. Forced diuresis, alkalinization
or urine, and hemoperfusion may not be useful. [USP DI 2007 & PDR 2007]
General information Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance
from an occupational health physician or other licensed health-care provider familiar 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 artificial respiration. If breathing is
difficult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic)
reactions must receive immediate medical attention.

5. Fire-fighting measures
Suitable extinguishing media Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and
materials.
Unsuitable extinguishing None known.
media
Specific hazards arising from No unusual fire or explosion hazards noted.
the chemical
Special protective equipment Wear suitable protective equipment.
and precautions for firefighters
Fire-fighting As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained
equipment/instructions breathing equipment and protective clothing.
Specific methods Cool containers exposed to flames with water until well after the fire is out.

6. Accidental release measures

Personal precautions, Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless
protective equipment and wearing appropriate protective clothing. Ensure adequate ventilation. Avoid inhalation of dust from
emergency procedures the spilled material. Wear appropriate personal protective equipment.
Methods and materials for Sweep up or vacuum up spillage and collect in suitable container for disposal. Avoid the
containment and cleaning up generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Wash spill
site.

7. Handling and storage

Precautions for safe handling As a general rule, when handling USP Reference Standards, avoid all contact and inhalation of
dust, mists, and/or vapors associated with the material. Clean equipment and work surfaces with
suitable detergent or solvent after use. After removing gloves, wash hands and other exposed
skin thoroughly. Use of a designated area is recommended for handling of potent materials.
Conditions for safe storage, Store in tight container as defined in the USP-NF. This material should be handled and stored per
including any incompatibilities label instructions to ensure product integrity.

8. Exposure controls/personal protection

Biological limit values No biological exposure limits noted for the ingredient(s).
Exposure guidelines No exposure standards allocated.

Material name: Mefenamic Acid USP SDS US

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Appropriate engineering Airborne exposure should be controlled primarily by engineering controls such as general dilution
controls ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally
preferred 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 effectiveness of engineering controls. Effectiveness of engineering controls
intended for use with highly potent materials should be assessed by use of nontoxic surrogate
materials.
Local exhaust ventilation such as a laboratory fume hood or other vented enclosure is
recommended, particularly for grinding, crushing, weighing, or other dust-generating procedures.
Individual protection measures, such as personal protective equipment
Eye/face protection Safety 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 preferred. Maintain eyewash facilities in the work area.
Skin protection
Hand 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.
Other For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significant
quantities are handled, work clothing may be necessary to prevent take-home contamination.
Respiratory protection Where respirators are deemed necessary to reduce or control occupational exposures, use
NIOSH-approved respiratory protection and have an effective respirator program in place
(applicable U.S. regulation OSHA 29 CFR 1910.134).
Thermal hazards Not available.
General hygiene Handle in accordance with good industrial hygiene and safety practice.
considerations

9. Physical and chemical properties

Appearance White to almost white microcrystalline powder.
Physical state Solid.
Form Powder.
Odor Odorless.
Odor threshold Not available.
pH Not available.
Melting point/freezing point 446 - 447.8 °F (230 - 231 °C)
Initial boiling point and boiling Not available.
range
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not applicable.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure < 0.0000001 kPa at 25 °C
1 mm Hg
Vapor density Not available.
Relative density Not available.
Solubility in water Insoluble.
Partition coefficient Not available.
(n-octanol/water)
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
Other information
Chemical family Fenamate derivative.
Molecular formula C15H15NO2
Material name: Mefenamic Acid USP SDS US
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 Molecular weight 241.28
Percent volatile 0.25 %

10. Stability and reactivity

Reactivity No reactivity hazards known.
Chemical stability Material is stable under normal conditions.
Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
Conditions to avoid None known.
Incompatible materials None known.
Hazardous decomposition NOx. Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions.
products

11. Toxicological information

Information on likely routes of exposure
Ingestion Harmful if swallowed.
Inhalation Due to lack of data the classification is not possible.
Skin contact Due to lack of data the classification is not possible.
Eye contact Due to lack of data the classification is not possible.
Symptoms related to the Nonsteroidal anti-inflammatory drugs: Upset stomach. Nausea. Vomiting. Diarrhea. Headache.
physical, chemical, and Dizziness. Ringing in ears. Blurred vision. Nervousness. Depression. Drowsiness. Difficulty
toxicological characteristics sleeping. Ulcers. Tiredness. Irritability. Constipation. Indigestion.
Delayed and immediate effects Nonsteroidal anti-inflammatory drugs: Hypertension. Coma. Respiratory depression.
of exposure Gastrointestinal bleeding. Central nervous system effects. Kidney impairment.
Cross sensitivity Persons sensitive to one NSAID may be sensitive to this material also.
Medical conditions aggravated Nonsteroidal anti-inflammatory drugs: Asthma. Aspirin allergy. Active alcoholism. Anemia.
by exposure Impaired kidney or liver function. Cardiovascular disorders. Bleeding disorders. Peptic ulcer or
gastrointestinal bleeding. Hypertension. Stomatitis.
Acute toxicity Harmful if swallowed.
Product Species Test Results
Mefenamic Acid (CAS 61-68-7)
Oral
LD50 Mouse 525 mg/kg
Rat 740 mg/kg
Skin corrosion/irritation Due to lack of data the classification is not possible.
Serious eye damage/eye Due to lack of data the classification is not possible.
irritation
Respiratory sensitization Due to lack of data the classification is not possible.
Skin sensitization Due to lack of data the classification is not possible.
Germ cell mutagenicity Due to lack of data the classification is not possible.
Carcinogenicity Due to lack of data the classification is not possible. This product is not considered to be a
carcinogen by IARC, ACGIH, NTP, or OSHA.
Reproductive toxicity Suspected of damaging fertility or the unborn child. Therapeutic use of nonsteroidal
anti-inflammatory agents (NSAIDS) during the second half of pregnancy is associated with
adverse effects in the fetus such as premature closure of the ductus arteriosus, which may lead to
persistent pulmonary hypertension in the newborn. Animal studies have shown that NSAIDS
administered during late pregnancy can cause prolonged gestation, difficult labor, delayed birth,
and decreased pup survival rates.
Specific target organ toxicity - Due to lack of data the classification is not possible.
single exposure
Specific target organ toxicity - Causes damage to organs (cardiovascular system, gastrointestinal tract) through prolonged or
repeated exposure repeated exposure.
Aspiration hazard Based on available data, the classification criteria are not met.

12. Ecological information

Ecotoxicity No ecotoxicity data noted for the ingredient(s).
Persistence and degradability No data is available on the degradability of this product.
Bioaccumulative potential Not available.
Mobility in soil Not available.
Material name: Mefenamic Acid USP SDS US
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Other adverse effects Not available.

13. Disposal considerations

Disposal instructions Dispose in accordance with all applicable regulations.
Local disposal regulations Not available.
Hazardous waste code Not regulated.
Waste from residues / unused Empty containers or liners may retain some product residues. This material and its container must
products be disposed of in a safe manner (see: Disposal instructions).
Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal.
Since emptied containers may retain product residue, follow label warnings even after container is
emptied.

14. Transport information

DOT
Not regulated as a hazardous material by DOT.
IATA
Not regulated as a dangerous good.
Transport in bulk according to No information available.
Annex II of MARPOL 73/78 and
the IBC Code

15. Regulatory information

US federal regulations CERCLA/SARA Hazardous Substances - Not applicable.

One or more components are not listed on TSCA.

Superfund Amendments and Reauthorization Act of 1986 (SARA)
Hazard categories Immediate Hazard - Yes
Delayed Hazard - No
Fire Hazard - Yes
Pressure Hazard - No
Reactivity Hazard - No
SARA 302 Extremely No
hazardous substance
SARA 311/312 Hazardous No
chemical
Other federal regulations
Safe Drinking Water Act Not regulated.
(SDWA)
Food and Drug Not regulated.
Administration (FDA)
US state regulations This product does not contain a chemical known to the State of California to cause cancer, birth
defects or other reproductive harm.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) Yes
Canada Domestic Substances List (DSL) Yes
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Substances in China (IECSC) No
Europe European Inventory of Existing Commercial Chemical Yes
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) Yes
Korea Existing Chemicals List (ECL) No
New Zealand New Zealand Inventory Yes
Philippines Philippine Inventory of Chemicals and Chemical Substances Yes
(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)

16. Other information, including date of preparation or last revision

Issue date 11-10-2003

Material name: Mefenamic Acid USP SDS US

5751 Version #: 02 Revision date: 08-26-2013 Issue date: 11-10-2003 5/6
Revision date 08-26-2013
Version # 02
Further information Not available.
Disclaimer USP Reference Standards are sold for chemical test and assay purposes only, and NOT for
human consumption. The information contained herein is applicable solely to the chemical
substance when used as a USP Reference Standard and does not necessarily relate to any other
use of the substance described, (i.e. at different concentrations, in drug dosage forms, or in bulk
quantities). USP Reference Standards are intended for use by persons having technical skill and
at their own discretion and risk. This information has been developed by USP staff from sources
considered reliable but has not been independently verified by the USP. Therefore, the USP
Convention cannot guarantee the accuracy of the information in these sources nor should the
statements contained herein be considered an official expression. NO REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE is made with respect to the information
contained herein.
Revision Information This document has undergone significant changes and should be reviewed in its entirety.

Material name: Mefenamic Acid USP SDS US

5751 Version #: 02 Revision date: 08-26-2013 Issue date: 11-10-2003 6/6