Sildenafil SDS/MSDS (Safety Data Sheet)

3.1 Substances
Product name: Sildenafil
CAS Number: 139755-83-2
PubChem CID: 135398744
Molecular formula: C22H30N6O4S
Molecular weight: 474.6 g/mol
IUPAC name: 5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,5-d]pyrimidin-7-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
Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. ... Advice for firefighters: Wear self contained breathing apparatus for fire fighting if necessary. /Sildenafil citrate/

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
Accident Release Measures. Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. Environmental precautions: Do not let product enter drains. Methods and materials for containment and cleaning up: Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal. /Sildenafil citrate/
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.
Product: Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material. Contaminated packaging: Dispose of as unused product. /Sildenafil citrate/
Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. /Sildenafil citrate/
Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed. /Sildenafil citrate/
Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. /Sildenafil citrate/
Control of environmental exposure: Do not let product enter drains. /Sildenafil citrate/
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.

7.1 Precautions for safe handling
Sildenafil powder for oral suspension should be stored below 30 °C in its original package to protect the drug from moisture. Reconstituted sildenafil oral suspension should be stored below 30 °C or in a refrigerator at 2-8 °C; the suspension should not be frozen.
Commercially available sildenafil citrate injection should be stored at 20-25 °C, but may be exposed to temperatures ranging from 15-30 °C.
Commercially available sildenafil citrate tablets should be stored at 25 °C, but may be exposed to 15-30 °C.
Keep container tightly closed in a dry and well-ventilated place. /Sildenafil citrate/

7.2 Conditions for safe storage, including any incompatibilities
Sildenafil powder for oral suspension should be stored below 30 °C in its original package to protect the drug from moisture. Reconstituted sildenafil oral suspension should be stored below 30 °C or in a refrigerator at 2-8 °C; the suspension should not be frozen.
Commercially available sildenafil citrate injection should be stored at 20-25 °C, but may be exposed to temperatures ranging from 15-30 °C.
Commercially available sildenafil citrate tablets should be stored at 25 °C, but may be exposed to 15-30 °C.
Keep container tightly closed in a dry and well-ventilated place. /Sildenafil citrate/
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: 189-190 °C
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: White to off-white crystalline powder; solubility in water: 3.5 mg/mL /Sildenafil citrate/
o) Partition coefficient: n-octanol/water: Log P (n-octanol/water): 1.5
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): 118 Ų
Complexity: 838

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
No additional toxicological information available.

12.1 Toxicity
Sildenafil's production and use in the formulation of drugs administered for treatment of erectile dysfunction and hypertension may result in its release to the environment through various waste streams. If released to air, an estimated vapor pressure of 1.9X10-17 mm Hg at 25 °C indicates sildenafil will exist solely in the particulate phase in the ambient atmosphere. Particulate-phase sildenafil will be removed from the atmosphere by wet and dry deposition. Sildenafil contains chromophores that absorb at wavelengths >290 nm and, therefore, may be susceptible to direct photolysis by sunlight. If released to soil, sildenafil is expected to have no mobility based upon an estimated Koc of 27,000. The estimated pKa of sildenafil is 5.99, indicating that this compound will partially exist 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 surfaces is not expected based upon an estimated Henry's Law constant of 7.2X10-21 atm-cu m/mole. Volatilization from dry soil is not expected based on its estimated vapor pressure. Biodegradation data were not available. If released into water, sildenafil is expected to adsorb to suspended solids and sediment based upon the estimated Koc. Volatilization from water surfaces is not expected to be an important fate process based upon the estimated Henry's Law constant. An estimated BCF of 30 suggests the potentia

12.2 Persistence and degradability
No data available.

12.3 Bioaccumulative potential
Log P (n-octanol/water): 1.5
Low potential for bioaccumulation (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
This substance is classified as hazardous to the aquatic environment.

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: Registered (REACH Active)

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
Environmental 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 identifies currently marketed prescription drug products, incl sildenafil citrate, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Sildenafil citrate/

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: 2026/09/09
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.