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King of Chemicals Manufacturers Amlodipine Besilate or Amlodipine Besylate and API BP Ph Eur EP USP NF IP JP ChP PPRC Reagent FCC Food Grade Manufacturer |
Specifications, Properties, Uses, SDS of Amlodipine Besilate BP Ph Eur EP or Amlodipine Besylate USP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 111470-99-6. | |
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Muby Chem Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies of Amlodipine Besilate BP Ph Eur EP or Amlodipine Besylate USP Grade for actual users, including retail or small pack supplies for research and development work.
We supply fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, analytical reagent grade, API IP BP USP Ph Eur EP JP ChP PPRC and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals at best prices. We and/or our associated units have all the facilities to supply as per cGMP standard observing good manufacturing practice and good laboratory practice. We can assure low microbial count and also offer a test certificate for the same. We maintain warehouses across USA, India, and UAE. Our group exports to USA, Canada, Mexico, Argentina, Brazil, Chile, Korea, Malaysia, Thailand, Indonesia, Europe, and several other parts of the world. We supply in wholesale container loads to small pack of few grams. Solid products may be specified for it size and shape as desired by the buyer.
Amlodipine Besilate or Amlodipine Besylate CAS Number 111470-99-6
For Properties Specifications Uses of Amlodipine Besilate or Amlodipine Besylate Click Properties, Specifications, Uses, Price, Process of Amlodipine Besilate or Amlodipine Besylate Manufacturer.
For For SDS MSDS Sheet of Amlodipine Besilate or Amlodipine Besylate Click SDS Safety Data Sheet MSDS Sheet of Amlodipine Besilate or Amlodipine Besylate Manufacturer.
The Properties, Specifications, Monograph and Uses of Amlodipine Besilate or Amlodipine Besylate:
Amlodipine besylate is a prescription medication primarily used to treat high blood pressure or hypertension and to prevent chest pain or angina. It is called calcium channel blocker. It is used as a medecine for Hypertension or High Blood Pressure, Chronic Stable Angina, Vasospastic Angina, Coronary Artery Disease, etc.
Amlodipine Besilate BP Ph Eur Grade Specifications:
C26H31ClN2O8S --- 567.1 --- 111470-99-6
Action and use: Calcium channel blocker.
DEFINITION
3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate.
Content: 97.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: White or almost white powder.
Solubility: Slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol.
IDENTIFICATION
Infrared absorption spectrophotometry
TESTS
Optical rotation: -0.10° to + 0.10°.
Dissolve 0.250 g in methanol and dilute to 25.0 mL with the same solvent.
Related substances: To pass the test by Liquid chromatography.
In an airtight container, protected from light.
Amlodipine Besylate USP Grade Specifications:
C20H25ClN2O5-C6H6O3S --- 567.05
3,5-Pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, (±)-, monobenzenesulfonate.
3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate CAS 111470-99-6
Monohydrate 585.07
UNII: 864V2Q084H
UNII: 1J444QC288
Amlodipine Besylate is anhydrous or hydrated and contains not less than 97.0 percent and not more than 102.0 percent of C20H25ClN2O5-C6H6O3S, calculated on the anhydrous basis.
Packaging and storage: Preserve in tight containers, protected from light. Store at room temperature.
Labeling: Where it is the hydrated form, the label so indicates.
Identification:
A: Infrared Absorption.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Optical rotation: between -0.10° and +0.10°, measured at 20°.
Test solution: 10 mg per mL, in methanol.
Water Determination: not more than 0.5% for the anhydrous form. If labeled as the hydrated form, the limit is between 3.1% and 5.0%.
Residue on ignition: not more than 0.2%.
Related compounds and Assay: To pass the chromatographic test.
Amlodipine Besilate or Amlodipine Besylate is also manufactured in EP Grade.
The MSDS-SDS Hazard Statement of Amlodipine Besilate or Amlodipine Besylate:
Amlodipine Besilate or Amlodipine Besylate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
1. Product Identification
Product Name & Other Names: Amlodipine Besilate or Amlodipine Besylate.
CAS No.: 111470-99-6
EINECS EC Number: 1312995-182-4 (Internet)
Molecular Weight: 567.05
Chemical Formula: C26H31ClN2O8S
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
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
Skin corrosion/irritation Category 2, H315
Serious eye damage/eye irritation Category 2A, H319
Specific target organ toxicity, single exposure; Respiratory tract irritation Category 3, H335
Labeling according Regulation (EC) No 1272/2008
GHS Label Elements Irritant Harmful |
Signal Words: Warning
Hazard statements:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
Precautionary statements:
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash skin thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P332+313: If skin irritation occurs: Get medical advice/attention.
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.
P332+313: If skin irritation occurs: Get medical advice/attention.
P337+P313 If eye irritation persists: Get medical advice/ attention.
3. Composition/Information on Ingredients
Product Name & Other Names: Amlodipine Besylate.
CAS No.: 111470-99-6
EINECS EC Number: 1312995-182-4 (Internet)
4. First Aid Measures
Inhalation: Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Keep person warm and quiet; get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact: Immediately flush skin with plenty of soap and water for at least 15 minutes. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention if irritation develops.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention.
5. Fire Fighting Measures
Fire: May become a fire hazard at high temperatures.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Sulfur oxides, Hydrogen chloride gas.
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.
6. Accidental Release Measures
Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid dust formation. 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: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. 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. Do not leave the material container open. 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. Avoid dust formation and control ignition sources. Containers may be hazardous when empty.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: Contains no substances with occupational exposure limit values.
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.
9. Physical and Chemical Properties
Appearance: White to green powder or crystal.
Odor: Odorless.
Odor threshold: Not applicable.
pH: No data found.
Relative density: No data found.
Boiling Point:No data found.
Melting Point: 195C-212C
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: Not available.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Soluble in water and DMSO.
Viscosity: No data found.
10. Stability and Reactivity
Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Nitrogen sulfur & carbon oxides along with chlorine compounds.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flame, ignition sources, dusting and incompatibles.
11. Toxicological Information
LD50 Oral - Rat - 393 mg/kg.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.
12. Ecological Information
Persistence and Degradability: No data found.
Persistence and Degradability: No data found.
Mobility: No data found.
Bioaccumulation/ Accumulation: No data found.
Results of PBT and vPvB assessment: No data found.
13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Dispose of container and unused material in accordance with legal requirements.
14. Transport Information
DOT USA, TDG and ADR/RID Europe: Not dangerous goods.
IATA and IMDG/IMO: Not dangerous goods.
15. Regulatory Information
USA:
SARA 311/312 Hazardous Categorization: Seer section 2.
California Proposition 65: Not listed.
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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Amlodipine Besilate or Amlodipine Besylate Manufacturers, Suppliers, Exporters, Wholesalers:
King of Chemicals manufacturers
Plot No. 2900/46&47 + 2900/163to167, GIDC, Ankleshwar, Dist. Bharuch, India
India, USA, UAE
TEL: (Office) 91-22-65290111
email: info@kingofchemicals.com
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Our products are for industrial and laboratory use only. The user must test the material before use. We are not despensing chemists or druggist and do not offer over the counter type (OTC) products for medical use by individuals.
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Amlodipine Besilate or Amlodipine Besylate | |