SAFETY DATA SHEET

1. Identification
Product identifier Ketoconazole
Other means of identification
Catalog number 1356508
Chemical name Piperazine,
1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]
phenyl]-, cis-
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 RSTECH@usp.org
Emergency phone number CHEMTREC within US & 1-800-424-9300
Canada
CHEMTREC outside US & +1 703-527-3887
Canada

2. Hazard(s) identification
Note This product is supplied in a small quantity which does not constitute a combustible dust hazard.
The physical properties of this material indicate that in large quantities accumulated dust may be
hazardous.
Physical hazards Not classified.
Health hazards Acute toxicity, oral Category 3
Reproductive toxicity Category 1B
Specific target organ toxicity, repeated Category 2 (adrenal gland, liver)
exposure
OSHA hazard(s) Not classified.

Label elements

Signal word Danger

Hazard statement Toxic if swallowed. May damage fertility or the unborn child. May cause damage to organs
(adrenal gland, liver) through prolonged or repeated exposure.
Precautionary statement
Prevention Wash thoroughly after handling. Obtain special instructions before use. Do not handle until all
safety precautions have been read and understood. Wear protective gloves/protective
clothing/eye protection/face protection.
Response If swallowed: Immediately call a poison center/doctor. Rinse mouth. If exposed or concerned: Get
medical advice/attention.
Storage Store locked up.
Disposal Dispose of contents/container in accordance with local/regional/national/international regulations.
Hazard(s) not otherwise Not classified.
classified (HNOC)

3. Composition/information on ingredients
Substance
Material name: Ketoconazole USP SDS US
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Hazardous components
Chemical name Common name and synonyms CAS number %
Ketoconazole 65277-42-1 100

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 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 Liver damage.
symptoms/effects, acute and
delayed
Indication of immediate Treatment of imidazole antifungal overdose should be symptomatic and supportive and may
medical attention and special include the following: Toxicity after ingestion is unlikely. Gastrointestinal decontamination is
treatment needed generally unnecessary. For severe diarrhea or vomiting, monitor and correct fluid status.
(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 Use fire-extinguishing media appropriate for surrounding materials. Water. Foam. Dry chemical or
CO2.
Unsuitable extinguishing None known.
media
Specific hazards arising from Explosion hazard: Avoid generating dust; fine dust dispersed in air in sufficient concentrations and
the chemical in the presence of an ignition source is a potential dust explosion hazard.
Special protective equipment Wear suitable protective equipment.
and precautions for firefighters
Fire-fighting Use water spray to cool unopened containers. As with all fires, evacuate personnel to a safe area.
equipment/instructions Firefighters should use self-contained breathing equipment and protective clothing.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.

6. Accidental release measures

Personal precautions, Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive
protective equipment and mixture if they are released into the atmosphere in sufficient concentration. Keep unnecessary
emergency procedures 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 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. Clean
surface thoroughly to remove residual contamination.

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. Combustible dust clouds may be created where operations produce fine material
(dust). Avoid significant deposits of material, especially on horizontal surfaces, which may
become airborne and form combustible dust clouds and may contribute to secondary explosions.
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

Ketoconazole (CAS TWA 0.2 mg/m3
65277-42-1)
Biological limit values No biological exposure limits noted for the ingredient(s).
Material name: Ketoconazole USP SDS US
5584 Version #: 02 Revision date: 10-30-2014 Issue date: 12-30-2009 2/6
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 off-white powder.
Physical state Solid.
Form Powder.
Odor Odorless.
Odor threshold Not available.
pH 7.7 (at concentrations < 0.01 g/L)
Melting point/freezing point 298.4 - 305.6 °F (148 - 152 °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
Vapor density Not available.
Relative density Not available.
Solubility in water Practically insoluble.
Partition coefficient 3.78
(n-octanol/water)
4.34
Auto-ignition temperature 968 °F (520 °C)
Decomposition temperature Not available.
Viscosity Not available.
Other information
Chemical family Imidazole.

Material name: Ketoconazole USP SDS US

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 Dust explosion properties
Kst 174 bar.m/s
Minimum ignition 1 mJ
energy (MIE) - dust
cloud
Molecular formula C26H28Cl2N4O4
Molecular weight 531.43
Solubility (other) Sparingly soluble in alcohol; freely soluble in dichloromethane; soluble in methyl alcohol.

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 Acids. Strong bases.
Hazardous decomposition Cl-. 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 Toxic 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 Imidazole antifungals: Nausea. Vomiting. Diarrhea. Abdominal pain. Headache. Back pain. Fever.
physical, chemical, and Chills. Drowsiness. Fatigue. Dizziness. Skin rash. Itching. Blistering. Burning. Skin redness.
toxicological characteristics Flushing. Constipation. Loss of appetite. Visual disturbances. Yellowed eyes or skin. Swelling in
arms or legs. Difficulty breathing. Confusion. Depression. Sedation. Trembling. Convulsions.
Delayed and immediate effects Liver damage.
of exposure
Cross sensitivity Persons sensitive to one imidazole may be sensitive to this material also.
Medical conditions aggravated Alcoholism. Impaired liver function. Achlorhydria. Porphyria.
by exposure
Acute toxicity Toxic if swallowed.
Product Species Test Results
Ketoconazole (CAS 65277-42-1)
Acute
Oral
LD50 Dog 780 mg/kg
Guinea pig 202 mg/kg
Mouse 702 mg/kg
Rat 227 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 Based on available data, the classification criteria are not met.
Mutagenicity
Dominant lethal test in mice
Result: Negative.
Carcinogenicity Based on available data, the classification criteria are not met. This material is not considered to
be a carcinogen by IARC, NTP, or OSHA.
< 80 mg/kg/day Carcinogenicity study
Result: No evidence of carcinogenicity was seen in rats or
mice in a long-term feeding study.
Reproductive toxicity May damage fertility or the unborn child.

Material name: Ketoconazole USP SDS US

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 Reproductivity
800 - 1200 mg/kg/day Reproductivity study
Result: Therapeutic doses in men were reported to decrease
testosterone levels.
>= 80 mg/kg/day Reproductivity study
Result: Embryolethality was produced but no increase in
incidence of malformations.
Species: Rabbit
>= 80 mg/kg/day Reproductivity study
Result: Maternal toxicity, embryotoxicity, and congenital
abnormalities were seen.
Species: Rat
Specific target organ toxicity - Due to lack of data the classification is not possible.
single exposure
Specific target organ toxicity - May cause damage to organs (adrenal gland, liver) 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.
Other adverse effects Not available.

13. Disposal considerations

Disposal instructions 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
for hazardous waste.
Local disposal regulations Not available.
Hazardous waste code Not available.
Waste from residues / unused Dispose of in accordance with local regulations. Empty containers or liners may retain some
products product residues. This material and its container must 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
UN number UN2811
UN proper shipping name Toxic solid, organic, n.o.s. (Ketoconazole)
Transport hazard class(es) 6.1
Subsidiary class(es) Not available.
Packing group III
IATA
UN number UN2811
UN proper shipping name Toxic solid, organic, n.o.s. (Ketoconazole)
Transport hazard class(es) 6.1
Subsidiary class(es) -
Packaging group III
Transport in bulk according to No information available.
Annex II of MARPOL 73/78 and
the IBC Code
DOT; IATA

Material name: Ketoconazole USP SDS US

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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 - No
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 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) 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) No
Korea Existing Chemicals List (ECL) Yes
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 12-30-2009
Revision date 10-30-2014
Version # 02
Further information Refer to NFPA 654, Standard for the Prevention of Fire and Dust Explosions from the
Manufacturing, Processing, and Handling of Combustible Particulate Solids, for safe handling.
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: Ketoconazole USP SDS US

5584 Version #: 02 Revision date: 10-30-2014 Issue date: 12-30-2009 6/6