Felodipine IP BP EP Ph Eur USP Grade Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Felodipine, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Felodipine CAS Number 72509-76-3 or 86189-69-7, EINECS EC Number: 620-472-7, Molecular Formula: C18H19Cl2NO4, Molecular Weight: 384.25, HS Code 29333919
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SDS MSDS Sheet of Felodipine Manufacturers
Felodipine
IP BP EP Ph Eur USP Grade Suppliers
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. Reduction in blood pressure lowers the risk of cardiovascular morbidity and mortality.
General Properties and Specifications of Felodipine:
Appearance: Light yellow to yellow crystalline powder.
Solubility: freely soluble in acetone and methanol. Very slightly soluble in heptane. Insoluble in water.
Identification: by IR and by HPLC.
Assay: 98% to 101%
Residue on ignition: 0.1% maximum.
Loss on drying: 0.5% maximum.
Color of the solution 20mg/ml in methanol: < 0.2 absorbance.
Limit of Ethyl 3-Aminocrotanate: 0.15% maximum.
Methyl Benzylidene acetoacetate: 0.15% maximum.
Felodipine related compound A: 0.15% maximum.
Sum of dimethyl felodipine and diethyl felodipine: 1% maximum.
Any unspecified impurity: 0.1% maximum.
Total impurities: 1.5% maximum.
Residual solvent Isopropyl Alcohol: 5000 ppm maximum.
Particle size: D90 Less than 10 µm.
Relative Density: about 1.28
Melting Point: 145C literature.
Boiling Point: 472C literature.
Solubility: Practically insoluble in water.
Storage: At room temperature in light-resistant containers.
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.
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.
We also manufacture Felodipine IP EP Grade.
For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.
We also manufacture and supply as under:
Quetiapine Fumarate or Quetiapine Hemifumarate Salt
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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Last
22 September, 2024
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Felodipine SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 20-Jan-23
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
Molecular Weight: 384.25
Chemical Formula: C18H19Cl2NO4
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  Irritant |
GHS Label Elements |
GHS Label Elements |
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.
P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P314: Get Medical advice/attention if you feel unwell.
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.
P391: Collect spillage.
P501: Dispose of contents/container in accordance with local/regional/national/international regulation.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xn Harmful
N Dangerous for the environment.
Risk Phrases:
R22 Harmful if swallowed.
R48 Danger of serious damage to health by prolonged exposure.
R61 May cause harm to the unborn child.
R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
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. Material is not sensitive to impact or static discharge.
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. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.
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.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
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. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.
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.). Prevent any contact with hot surfaces.
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 contact with skin and eyes. 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. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
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. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
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: Not available.
Odor threshold: Not available.
pH (1% soln/water): Not available.
Relative density: about 1.28
Melting Point: 145C literature.
Initial boiling point and boiling range: 472C literature.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Practically insoluble in water.
Viscosity: Not available.
Molecular Weight: 384.25
Chemical Formula: C18H19Cl2NO4
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 information available.
Teratogenicity: No information available.
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: Acute Health Hazard, Chronic Health Hazard.
Section 16: Other Information
European Labeling in Accordance with EC Directives:
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.
Hazard Symbol:
Xn Harmful
N Dangerous for the environment.
Risk Phrases:
R22 Harmful if swallowed.
R48 Danger of serious damage to health by prolonged exposure.
R61 May cause harm to the unborn child.
R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
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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