SAFETY DATA SHEET

1. Identification
Product identifier Glimepiride
Other means of identification
Catalog number 1292303
Chemical name 1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-
3-(trans-4-methylcyclohexyl)urea
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 Not classified.
OSHA hazard(s) Not classified.

Label elements
Hazard symbol No symbol.
Signal word Not available.
Hazard statement Not available.
Precautionary statement
Prevention Not available.
Response Not available.
Storage Not available.
Disposal Not available.
Hazard(s) not otherwise Not classified.
classified (HNOC)

3. Composition/information on ingredients
Substance
Hazardous components
Chemical name Common name and synonyms CAS number %
Glimepiride 93479-97-1 100

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 Wash off with soap and water. Get medical attention if irritation develops and persists.
Eye contact Flush eyes with water as a precaution. 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.

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Most important Not available.
symptoms/effects, acute and
delayed
Indication of immediate Treatment of sulfonylurea overdose should be symptomatic and supportive and may include the
medical attention and special following: Do NOT induce vomiting. Administer activated charcoal as a slurry. Perform gastric
treatment needed lavage soon after ingestion. Control any seizures first. For symptomatic hypoglycemia, treat with
food and intravenous dextrose. Once corrected, follow with octreotide. Prophylactic dextrose is
NOT recommended in patients who do not become hypoglycemic. For hypoglycemic seizures,
treat with glucose replacement. Monitor blood glucose and vital signs hourly. Monitor for
hypoglycemia. Hemodialysis is unlikely to be of value. (Poisindex)
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. Avoid inhalation of dust from the spilled material. Ensure
emergency procedures adequate ventilation. 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.
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

Exposure limit values
Industrial Use

Material Type Value

Glimepiride (CAS TWA 0.01 mg/m3
93479-97-1)
Biological limit values No biological exposure limits noted for the ingredient(s).
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.
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 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 crystalline powder.
Physical state Solid.
Form Powder.
Odor Odorless or practically odorless.
Odor threshold Not available.
pH Not available.
Melting point/freezing point 393.8 - 419 F (201 - 215 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 Not available.
Vapor density Not available.
Relative density Not available.
Solubility in water Practically insoluble.
Partition coefficient Not available.
(n-octanol/water)
Auto-ignition temperature > 752 F (> 400 C)
Decomposition temperature Not available.
Viscosity Not available.
Other information
Chemical family Sulfonylurea.
Molecular formula C24H34N4O5S
Molecular weight 490.62
Solubility (other) Soluble in dimethylformamide, in dilute alkali hydroxides, and in dilute acids; slightly soluble in
methanol; sparingly soluble in methylene chloride.

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.

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Hazardous decomposition NOx. SOx. Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions.
products

11. Toxicological information

Information on likely routes of exposure
Ingestion Based on available data, the classification criteria are not met.
Inhalation Due to lack of data the classification is not possible.
Skin contact Based on available data, the classification criteria are not met.
Eye contact Based on available data, the classification criteria are not met.
Symptoms related to the Sulfonylureas: Headache. Nausea. Vomiting. Constipation. Diarrhea. Flatulence. Heartburn.
physical, chemical, and Stomach pain or fullness. Change in appetite. Weight gain. Taste disturbances. Increased
toxicological characteristics urination. Vision changes. Increased sensitivity of skin to sunlight. Tingling, prickling, or
numbness of skin. Slurred speech. Skin redness. Itching. Skin rash. Peeling skin. Anxiety.
Confusion. Unsteadiness. Nervousness. Shakiness. Drowsiness. Dizziness. Weakness. Difficulty
concentrating. Nightmares. Restless sleep. Cool, pale skin. Seizures.
Delayed and immediate effects Sulfonylureas: Fast heartbeat. Hypoglycemia. Coma.
of exposure
Cross sensitivity Persons sensitive to sulfonamides may be sensitive to this material also.
Medical conditions aggravated Sulfonylureas: Alcoholism. Blood disorders. Porphyria. Diabetic ketoacidosis. Adrenal or pituitary
by exposure impairment. Gastrointestinal problems. Fluid retention. Heart or blood vessel disorders.
Congestive heart failure. Hyperthyroidism. Kidney impairment. Liver impairment.
Acute toxicity Based on available data, the classification criteria are not met.
Product Species Test Results
Glimepiride (CAS 93479-97-1)
Oral
LD50 Mouse > 10000 mg/kg
Rat > 10000 mg/kg
Skin corrosion/irritation Based on available data, the classification criteria are not met.
Serious eye damage/eye Based on available data, the classification criteria are not met.
irritation
Local effects
Irritancy test
Result: Non-irritant.
Species: Rabbit
Organ: Eyes
Irritancy test
Result: Non-irritant.
Species: Rabbit
Organ: Skin
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 Based on available data, the classification criteria are not met.
Negative in in vitro and in vivo genotoxicity tests.
Carcinogenicity Based on available data, the classification criteria are not met.
This product is not considered to be a carcinogen by IARC, ACGIH, NTP, or OSHA.
320 mg/kg Carcinogenicity study
Result: No evidence of carcinogenicity.
Species: Beagle dog
Test Duration: 12 months
320 ppm Carcinogenicity study
Result: Dose-related increase in benign pancreatic adenoma
formation.
Species: Mouse
Test Duration: 24 months
5000 ppm Carcinogenicity study
Result: No evidence of carcinogenicity.
Species: Rat
Test Duration: 30 months
50000 ppm Carcinogenicity study
Result: No evidence of carcinogenicity.
Species: Rat
Test Duration: 12 months

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Reproductive toxicity Based on available data, the classification criteria are not met.
Therapeutic use of sulfonylureas at the time of delivery has been associated with prolonged,
severe hypoglycemia in newborns.
This material has not caused birth defects in animal studies. No fertility impairing effects were
seen in animal studies.
Reproductivity
Reproductivity study, doses 0.1 times the human dose
Result: Dose-related intrauterine fetal death and maternal
hypoglycemia.
Species: Rabbit
Reproductivity study, doses 50 times the human dose
Result: Dose-related intrauterine fetal death and maternal
hypoglycemia.
Species: Rat
Specific target organ toxicity - Based on available data, the classification criteria are not met.
single exposure
Specific target organ toxicity - Based on available data, the classification criteria are not met.
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.
Other adverse effects Not available.

13. Disposal considerations

Disposal instructions This product, in its present state, when discarded or disposed of, is not a hazardous waste
according to Federal regulations (40 CFR 261.4 (b)(4)). 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 for hazardous waste. 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 - No
Delayed Hazard - No
Fire Hazard - No
Pressure Hazard - No
Reactivity Hazard - No
SARA 302 Extremely No
hazardous substance
SARA 311/312 Hazardous No
chemical

Material name: Glimepiride USP SDS US

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Other federal regulations
Safe Drinking Water Act Not regulated.
(SDWA)
Food and Drug Not regulated.
Administration (FDA)
US state regulations California Safe Drinking Water and Toxic Enforcement 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
China Inventory of Existing Chemical Substances in China (IECSC) No
Europe European Inventory of Existing Commercial Chemical No
Substances (EINECS)
Europe European List of Notified 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 Yes
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)

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

Issue date 04-30-2008
Revision date 04-30-2013
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: Glimepiride USP SDS US

5346 Version #: 02 Revision date: 04-30-2013 Issue date: 04-30-2008 6/6