Amlodipine SDS/MSDS (Safety Data Sheet)

3.1 Substances
Product name: Amlodipine
CAS Number: 88150-42-9
PubChem CID: 2162
Molecular formula: C20H25ClN2O5
Molecular weight: 408.9 g/mol
IUPAC name: 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

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. /Amlodipine besylate/
Advice for firefighters: Wear self-contained breathing apparatus for firefighting if necessary. /Amlodipine besylate/

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.
WARNING: Highly toxic — only trained personnel should handle spills.

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
ACCIDENTAL 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. 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. /Amlodipine besylate/
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. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber; Contaminated packaging: Dispose of as unused product. /Amlodipine besylate/
ACCIDENTAL 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. Avoid breathing dust. Environmental precautions: Do not let product enter drains. /Amlodipine besylate/
Precautions for safe handling: Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Further processing of solid materials may result in the formation of combustible dusts. The potential for combustible dust formation should be taken into consideration before additional processing occurs. Provide appropriate exhaust ventilation at places where dust is formed. /Amlodipine besylate/
Appropriate engineering controls: Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. /Amlodipine besylate/
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. /Amlodipine besylate/
For more Preventive Measures (Complete) data for AMLODIPINE (6 total), please visit the HSDB record page.

7.1 Precautions for safe handling
Keep container tightly closed in a dry and well-ventilated place. /Amlodipine besylate/
Store bottles at controlled room temperature, 59 deg to 86 °F (15 deg to 30 °C) and dispense in tight, light-resistant containers.

7.2 Conditions for safe storage, including any incompatibilities
Keep container tightly closed in a dry and well-ventilated place. /Amlodipine besylate/
Store bottles at controlled room temperature, 59 deg to 86 °F (15 deg to 30 °C) and dispense in tight, light-resistant containers.
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: 199-201
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: slightly soluble in water
o) Partition coefficient: n-octanol/water: Log P (n-octanol/water): 3
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): 99.9 Ų
Complexity: 647

11.1 Information on toxicological effects
Acute toxicity:
No acute toxicity data available.
Skin corrosion/irritation:
Causes severe skin burns and eye damage (H314).
Serious eye damage/eye irritation:
Causes serious eye damage (H318).
Respiratory or skin sensitization:
No data available.
Germ cell mutagenicity:
Suspected of causing genetic defects (H341).
Carcinogenicity:
No data available.
Reproductive toxicity:
No data available.
Specific target organ toxicity (single exposure):
H373
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
Amlodipine's production and administration as a medication may result in its release to the environment through various waste streams. If released to air, an estimated vapor pressure of 1.2X10-9 mm Hg at 25 °C indicates amlodipine will exist solely in the particulate phase in the atmosphere. Particulate-phase amlodipine will be removed from the atmosphere by wet and dry deposition. Amlodipine contains chromophores that absorb at wavelengths >290 nm and, therefore, may be susceptible to direct photolysis by sunlight. If released to soil, amlodipine is expected to have slight mobility based upon an estimated Koc of 3200. Volatilization from moist soil surfaces is not expected to be an important fate process based upon an estimated Henry's Law constant of 2.9X10-17 atm-cu m/mole. Amlodipine is not expected to volatilize from dry soil surfaces based upon its vapor pressure. A biodegradation of 3% in 28 days using an aqueous ready biodegradability test suggests that biodegradation is not an important environmental fate process in soil and water. If released into water, amlodipine 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 this compound's estimated Henry's Law constant. An estimated BCF of 44 suggests the potential for bioconcentration in aquatic organisms is moderate. Hydrolysis is not expected to be an important environmental fate process since t

12.2 Persistence and degradability
No data available.

12.3 Bioaccumulative potential
Log P (n-octanol/water): 3
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: Yes (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: Subject to EPA TSCA regulations
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
Chronic (long-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, including amlodipine besylate, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Amlodipine besylate/

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.