CAS Number 72509-76-3 or 86189-69-7, Felodipine USP EP BP Ph Eur IP Grade Manufacturers Exporters

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Felodipine EP BP IP USP Manufacturers Exporters
CAS Number 72509-76-3 or 86189-69-7, Felodipine USP EP BP Ph Eur IP Manufacturer Exporter

For Properties Specifications of Felodipine Click Properties, Specifications of Felodipine Manufacturer.

For Uses of Felodipine Click Uses of Felodipine Manufacturer.

For For SDS MSDS Sheet of Felodipine Click SDS Safety Data Sheet MSDS Sheet of Felodipine Manufacturer.

The Properties and Specifications of Felodipine:

Felodipine BP Ph Eur Grade:
C18H19Cl2NO4 --- 384.3 --- CAS 72509-76-3
Action and use: Calcium channel blocker.

DEFINITION
Ethyl methyl (4RS)-4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or light yellow, crystalline powder.
Solubility: Practically insoluble in water, freely soluble in acetone, in anhydrous ethanol, in methanol and in methylene chloride.

IDENTIFICATION
First identification: B
Second identification: A, C, D
A. Ultraviolet and visible absorption spectrophotometry.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography
D. Ultraviolet and visible absorption spectrophotometry.

Solution S: Dissolve 1.00 g in methanol and dilute to 20.0 mL with the same solvent.
Appearance of solution: Solution S is clear.
Absorbance: Maximum 0.10, determined at 440 nm on solution S.
Related substances: To pass the test.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C for 3 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.


Felodipine USP Grade Specifications:
C18H19Cl2NO4 --- 384.25
3,5-Pyridinedicarboxylic acid 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, ethyl methyl ester, (±)-;
(±)-Ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate CAS 72509-76-3, 86189-69-7
UNII: OL961R6O2C

DEFINITION
Felodipine contains NLT 98.0% and NMT 101.0% of felodipine (C18H19Cl2NO4), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test. Maximum 1.5%
Loss on Drying: Dry the sample at 105C for 3 h. Acceptance criteria: NMT 0.5%
Color of Solution: To pass the test.


We also supply Felodipine IP EP Grade.


The Uses of Felodipine:

Felodipine is a medication used in the management and treatment of essential hypertension. It is a member of the dihydropyridine class of calcium channel blockers.


The MSDS-SDS Hazard Statement of Felodipine:

Felodipine SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
 16-Nov-24

Section 1: Product and Company Identification

Product Name & Other Names: Felodipine.
CAS No.: 72509-76-3 or 86189-69-7
EINECS, EC Number: 620-472-7
Relevant uses and uses advised against (if any): Laboratory chemicals, Manufacture of substances
Supplier: As per letterhead.

Section 2: Hazards Identification

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Acute toxicity, Oral (Category 4), H302
Reproductive toxicity, (Category 2) H361d
Specific target organ toxicity - repeated exposure (Category 2), H373
Chronic aquatic toxicity (Category 1), H410

Labeling according to GHS & Regulation (EC) No 1272/2008

GHS Label Elements
Harmful
Harmful

GHS Label Elements
Health Problem
Health Problem

GHS Label Elements
Marine Pollutant
Marine Pollutant

Signal Words: Danger

Hazard statements:
H302: Harmful if swallowed.
H361d: Suspected of damaging the unborn child.
H373: May causes damage to organs through prolonged or repeated exposure.
H410: Very toxic to aquatic life with long lasting effects.

Precautionary statements:
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P264 Wash thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Section 3: Composition / Information on Ingredients

Product Name & Other Names: Felodipine.
CAS No.: 72509-76-3 or 86189-69-7
EINECS, EC Number: 620-472-7

Section 4: First Aid Measures

Always seek medical attention after first aid measures are provided.

Eyes: Immediately flush eyes with excess water for 15 minutes, lifting lower and upper eyelids occasionally.
Skin: Immediately flush skin with excess water for 15 minutes while removing contaminated clothing.
Ingestion: Call Emergency Medical immediately. Rinse mouth with cold water. Give the victim 1-2 cups of water or milk to drink. Induce vomiting immediately.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration.

Section 5: Fire Fighting Measures

Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Avoid solid water jet as it can scatter fire.
Protective equipment and precautions for firefighters: Use water spray, foam, or dry chemical to extinguish fire. Firefighters should wear full firefighting turn-out gear and respiratory protection. Cool container with water spray.
Special hazards arising from the substance: Carbon oxides, Nitrogen oxides (NOx), Chlorine compounds.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode.

Section 6: Accidental Release Measures

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container.

Section 7: Handling and Storage Green

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Storage: At room temperature in light-resistant containers.

Section 8: Exposure Controls / Personal Protection

Exposure guidelines: Not Available.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice.

Section 9: Physical and Chemical Properties

Physical state and appearance: Light yellow to yellow crystalline powder.
Odor: No data found.
Odor threshold: No data found.
pH (1% soln/water): No data found.
Relative density: about 1.28
Melting Point: 145C literature.
Initial boiling point and boiling range: 472C literature.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Practically insoluble in water.
Viscosity: No data found.

Section 10: Stability and Reactivity

Stability: Stable under normal conditions of use and storage.
Incompatibility: Heat, light, and strong oxidizing agents.
Hazardous Decomposition Products: Carbon oxides, Nitrogen oxides (NOx), Chlorine compounds.
Hazardous Polymerization: Has not been reported.

Section 11: Toxicology Information

LD50 Oral - Mouse - 1050 mg/kg.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible, or confirmed human carcinogen by IARC.
May causes damage to organs (Kidney) through prolonged or repeated exposure.
Reproductive Effects: Suspected of damaging the unborn child.
Developmental Effects: No data found.
Teratogenicity: No data found.
Inhalation - May cause damage to organs through prolonged or repeated exposure.

Section 12: Ecological Information

Toxicity to fish: LC50 - Rainbow darter (Etheostoma caeruleum) – 0.05 mg/l - 96 h.
Toxicity to daphnia and other aquatic invertebrates: LC50 - Daphnia magna (Water flea) - 0,62 mg/l - 48 h.
Results of PBT and vPvB assessment: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

Section 13: Disposal Considerations

Check with all applicable local, regional, and national laws and regulations.

Section 14: Transport Information

DOT USA, TDG Canada & ADR/RID Europe:
UN-No: UN3077
Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (Felodipine).
Hazard Class: 9; Packing Group: III.
IATA & IMDG/IMO
UN-No: UN3077
Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (Felodipine).
Hazard Class: 9; Packing Group: III.

Section 15: Regulatory Information

USA:
SARA 311/312 Hazard Categories
: See section 2.

Section 16: Other Information

Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.

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Felodipine Structure

CAS Number 72509-76-3 or 86189-69-7, Felodipine Manufacturer Exporter

ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA

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Copyright. 18-nov-24

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Felodipine.