Itraconazole SDS/MSDS (Safety Data Sheet)

3.1 Substances
Product name: Itraconazole
CAS Number: 84625-61-6
PubChem CID: 55283
Molecular formula: C35H38Cl2N8O4
Molecular weight: 705.6 g/mol
IUPAC name: 2-butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one

3.2 Mixtures
Not applicable (pure substance).

4.1 Description of first aid measures
Inhalation: Move to fresh air. Keep at rest in a position comfortable for breathing. Seek medical attention if symptoms persist.
Skin contact: Wash with plenty of soap and water. Remove contaminated clothing. Seek medical attention if irritation develops.
Eye contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Seek medical attention.
Ingestion: Rinse mouth. Do NOT induce vomiting unless directed by medical personnel. Seek medical attention.

4.2 Most important symptoms and effects, both acute and delayed
See Section 11 (Toxicological Information).

4.3 Indication of any immediate medical attention and special treatment needed
Treat symptomatically. Contact a poison control center or physician for severe exposure.

5.1 Extinguishing media
Suitable: Water spray, dry chemical, carbon dioxide (CO2), alcohol-resistant foam.
Unsuitable: None known.

5.2 Specific hazards arising from the substance or mixture
Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.
As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

5.3 Advice for firefighters
Wear self-contained breathing apparatus (SCBA) and full protective clothing.
Fight fire from upwind. Cool containers with water spray until fire is extinguished.

6.1 Personal precautions, protective equipment and emergency procedures
Wear appropriate personal protective equipment (see Section 8).
Avoid breathing dust/vapor. Ensure adequate ventilation.
Evacuate personnel to safe areas. Keep people away from and upwind of spill.

6.2 Environmental precautions
Prevent product from entering drains, waterways, or soil.
Contain spill with inert absorbent material.

6.3 Methods and materials for containment and cleaning up
Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high-efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately -labelled container for disposal. Wash spill site.
SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.
SRP: At the time of review, regulatory criteria for small quantity disposal are subject to significant revision, however, household quantities of waste pharmaceuticals may be managed as follows: Mix with wet cat litter or coffee grounds, double bag in plastic, discard in trash.
SRP: Local exhaust ventilation should be applied wherever there is an incidence of point source emissions or dispersion of regulated contaminants in the work area. Ventilation control of the contaminant as close to its point of generation is both the most economical and safest method to minimize personnel exposure to airborne contaminants. Ensure that the local ventilation moves the contaminant away from the worker.
This material is assumed to be combustible. As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.
As a general rule, when handling USP Reference Standards avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.
/Wear/ chemically compatible gloves, safety glasses or goggles /and/ protect exposed skin.

7.1 Precautions for safe handling
Itraconazole capsules should be stored at a controlled room temperature of 15-25 °C and protected from light and moisture. Itraconazole oral solution should be stored at 25 °C or lower and should not be frozen.
Commercially available itraconazole injection should be stored at 25 °C or lower and protected from light; freezing should be avoided. Following dilution of itraconazole injection in the 0.9% sodium chloride injection diluent supplied by the manufacturer, itraconazole injections may be stored at 2-8 deg or 15-25 °C for up to 48 hours. The injection should be protected from light during storage, but may be exposed to normal room light during administration.
Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity.

7.2 Conditions for safe storage, including any incompatibilities
Itraconazole capsules should be stored at a controlled room temperature of 15-25 °C and protected from light and moisture. Itraconazole oral solution should be stored at 25 °C or lower and should not be frozen.
Commercially available itraconazole injection should be stored at 25 °C or lower and protected from light; freezing should be avoided. Following dilution of itraconazole injection in the 0.9% sodium chloride injection diluent supplied by the manufacturer, itraconazole injections may be stored at 2-8 deg or 15-25 °C for up to 48 hours. The injection should be protected from light during storage, but may be exposed to normal room light during administration.
Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity.
Store away from incompatible materials (see Section 10).
[Note: Specific storage temperature not available in public databases. Refer to supplier Certificate of Analysis (COA) for exact storage conditions.]

9.1 Information on basic physical and chemical properties
a) Appearance: Solid
b) Odor: No data available
c) Odor threshold: No data available
d) pH: No data available
e) Melting point/freezing point: 168-170
f) Initial boiling point and boiling range: No data available
g) Flash point: No data available
h) Evaporation rate: No data available
i) Flammability (solid, gas): No data available
j) Upper/lower flammability or explosive limits: No data available
k) Vapor pressure: No data available
l) Vapor density: No data available
m) Relative density: No data available
n) Water solubility: Practically insoluble in water and dilute acidic solutions
o) Partition coefficient: n-octanol/water: Log P (n-octanol/water): 5.7
p) Auto-ignition temperature: No data available
q) Decomposition temperature: No data available
r) Viscosity: No data available
s) Explosive properties: No data available
t) Oxidizing properties: No data available

9.2 Other information
Topological Polar Surface Area (TPSA): 101 Ų
Complexity: 1120

11.1 Information on toxicological effects
Acute toxicity:
No acute toxicity data available.
Skin corrosion/irritation:
Causes skin irritation (H315).
Serious eye damage/eye irritation:
Causes serious eye irritation (H319).
Respiratory or skin sensitization:
No data available.
Germ cell mutagenicity:
No data available.
Carcinogenicity:
No data available.
Reproductive toxicity:
No data available.
Specific target organ toxicity (single exposure):
No data available.
Specific target organ toxicity (repeated exposure):
No data available.
Aspiration hazard:
No data available.

11.2 Additional information
Carcinogen classification:
No indication of carcinogenicity to humans (not listed by IARC).
Exposure routes:
The absolute oral bioavailability of itraconazole is 55%, and is maximal when taken with a full meal.
Data source: Hazardous Substances Data Bank (HSDB) via PubChem.

12.1 Toxicity
Itraconazole's production and use as medication may result in its release to the environment through various waste streams. If released to air, an estimated vapor pressure of 2.6X10-20 mm Hg at 25 °C indicates itraconazole will exist solely in the particulate phase in the atmosphere. Particulate-phase itraconazole will be removed from the atmosphere by wet or dry deposition. Itraconazole does not contain chromophores that absorb at wavelengths >290 nm, and therefore is not expected to be susceptible to direct photolysis by sunlight. If released to soil, itraconazole is expected to have no mobility based upon an estimated Koc of 6,600. The pKa of itraconazole is 3.7, indicating that this compound will exist almost entirely in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts. Volatilization from moist soil is not expected because the compound exists as a cation and cations do not volatilize. A biodegradation model indicates persistence on the order of months and longer, suggesting that biodegradation is not expected to be an important environmental fate process in water. If released into water, itraconazole is expected to adsorb to suspended solids and sediment based upon the estimated Koc. A pKa of 3.7 indicates itraconazole will exist almost entirely in the cation form at pH values of 5 to 9 and therefore volatilization from water surfaces is not expected to be an importan

12.2 Persistence and degradability
No data available.

12.3 Bioaccumulative potential
Log P (n-octanol/water): 5.7
Potential for bioaccumulation exists (Log P > 3).

12.4 Mobility in soil
No data available.

12.5 Results of PBT and vPvB assessment
PBT/vPvB assessment not available.

12.6 Other adverse effects
No other adverse ecological effects identified.

13.1 Waste treatment methods
Waste Treatment Methods: Waste material must be disposed of in accordance with national and local regulations. Leave chemicals in original containers and do not mix with other waste. Handle uncleaned containers in the same manner as the product itself.

14.1 UN number
Not regulated as dangerous goods (research quantities typically exempt).

14.2 UN proper shipping name
Not subject to transport regulations (small quantities for research use).

14.3 Transport hazard class(es)
Not classified as dangerous goods for transport (research quantities).

14.4 Packing group
Not applicable (not regulated as dangerous goods in typical research quantities).

14.5 Environmental hazards
Marine pollutant: No (not classified as environmentally hazardous per GHS).

14.6 Special precautions for user
Transport in original packaging. Ensure containers are tightly sealed.
For bulk or commercial quantities, consult applicable transport regulations (DOT, IATA, IMDG).

14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable.

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
US EPA / TSCA: Not available in public databases.
EU ECHA / REACH: Not available in public databases.

SARA 302 Components:
No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components:
This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards:
Acute (short-term) health hazard

Massachusetts Right To Know Components:
This material contains components subject to the Massachusetts Right to Know Act. See Section 2 for hazard classification.
Pennsylvania Right To Know Components:
This material contains components subject to the Pennsylvania Right to Know Act. See Section 2 for hazard classification.
New Jersey Right To Know Components:
This material contains components subject to the New Jersey Right to Know Act. See Section 2 for hazard classification.

California Prop. 65 Components:
This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.

Other regulatory listings:
- FDA Requirements: The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, including itraconazole, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.

15.2 Chemical safety assessment
A chemical safety assessment has not been carried out for this substance.
For research-use-only compounds, no CSA is required under REACH Annex I.

Revision Date: 2026/09/08
Further Information: The information provided is believed to be correct but is not exhaustive and should be used only as a guideline based on current knowledge. It does not represent a guarantee of the properties of the product. Selleck Chemicals Corporation and its Affiliates shall not be held liable for any damage resulting from handling or contact with the product.