Montelukast Sodium BP Ph Eur EP IP USP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Montelukast Sodium BP Ph Eur EP IP USP Grade, 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.

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Montelukast Sodium CAS Number 151767-02-1, EINECS EC Number: 604-813-7, Molecular Formula: C35H35ClNNaO3S, Molecular Weight: 608.17, HS Code 29334922 or 29334900 or 29334990

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Montelukast Sodium.

Montelukast is commonly used for the long-term treatment of asthma and to prevent symptoms of exercise-induced asthma. Montelukast is also used to help control the symptoms of allergies such as sneezing, stuffy, runny, and itchy nose.

General Properties and Specifications of Montelukast Sodium:
Appearance: White to almost white powder or crystals.
Assay: >99%
Melting Point: 115C literature.
Solubility: Soluble in water and DMSO.
Storage: Room Temperature. Recommended in a cool and dark place, <15C. Light Sensitive. Hygroscopic.

Montelukast Sodium USP Grade Specifications:
C35H35ClNNaO3S --- 608.17
Cyclopropaneacetic acid, 1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-, sodium salt, [R-,(E)]-;
Sodium 1-[[[(R)-m-[(E)-2-(7-chloro-2-quinolyl)vinyl]-α-[o-(1-hydroxy-1-methylethyl)phenethyl]benzyl]thio]-methyl]cyclopropaneacetate CAS 151767-02-1
C35H36ClNO3S --- 586.18
Montelukast CAS 158966-92-8
UNII: U1O3J18SFL
UNII: MHM278SD3E

DEFINITION
Montelukast Sodium contains NLT 98.0% and NMT 102.0% of C35H35ClNNaO3S, calculated on the anhydrous and solvent-free basis.

IDENTIFICATION
A. Infrared Absorption
B. Identification Tests—General, Sodium
C. Meets the requirements of the test for Enantiomeric Purity.
Organic Impurities: To pass the test by chromatography.
Enantiomeric purity: To pass the test by chromatography.
Water Determination: NMT 4.0%
Packaging and Storage: Preserve in tight containers, protected from light. Store at room temperature.

Montelukast Sodium BP Ph Eur Grade:
C35H35ClNNaO3S --- 608 --- CAS 151767-02-1
Action and use: Leukotriene CysLT1 receptor antagonist; treatment of asthma.

DEFINITION
Sodium [1-[[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, hygroscopic powder.
Solubility: Freely soluble in water and in methylene chloride, freely soluble to very soluble in ethanol (96 per cent).

IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Enantiomeric purity.
C. Ignite 0.1 g in a crucible until an almost white residue is obtained. Take up the residue in 2 mL of water and filter. The filtrate gives reaction of sodium.

TESTS
Enantiomeric purity: To pass the test by liquid chromatography.
Related substances: To pass the test by liquid chromatography.
Water: Maximum 4.0 per cent, determined on 0.300 g.
Storage: In an airtight container, protected from light.

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.

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Montelukast Sodium SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 27-Aug-24

Product Name & Other Names: Montelukast Sodium.
CAS Number: 151767-02-1
EINECS EC Number: 604-813-7
Molecular Formula: C35H35ClNNaO3S
Molecular Weight: 608.17
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

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

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.

Product Name & Other Names: Montelukast Sodium.
CAS Number: 151767-02-1
EINECS EC Number: 604-813-7

Emergency and First Aid Procedures:
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If swallowed, if conscious, give plenty of water. Immediately call a physician.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Keep a person warm, quiet, and get medical attention.

Extinguisher Media: Use water spray, alcohol-resistant foam, dry chemical, Aor carbon dioxide. Avoid solid water jet.
Special Fire fighting Procedures: Firefighters should wear full protective equipment and NIOSH approved self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: Heated to decomposition, however, toxic oxides of sulfur, chlorine compounds, oxides of nitrogen and oxides of carbon along with sodium compounds and fumes may be evolved.
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.

Personal precautions, protective equipment, and emergency procedures: Ventilate area of spill. Avoid creating dust. 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: 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.

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. Provide appropriate exhaust ventilation at places where dust is formed. 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. Do not leave the material container open. 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: Room Temperature. Recommended in a cool and dark place, <15C. Light Sensitive. Hygroscopic.

Exposure limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Respiratory Protection (Specify Type): None needed under normal conditions of use with adequate ventilation. NIOSH approved equipment should be worn if PELs are exceeded.
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. Wash hands after handling.

Physical State: White to almost white powder or crystals.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting Point: 115C literature.
Initial boiling point and boiling range: Not available.
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: Soluble in water and DMSO.
Viscosity: Not available.
Molecular Formula: C35H35ClNNaO3S
Molecular Weight: 608.17

Stability: Stable.
Conditions to Avoid: Dust generation, Incompatibles
Incompatibility (Materials to Avoid): Strong oxidizing agents.
Hazardous Decomposition Products: Oxides of sulfur, chlorine compounds, nitrogen, and carbon along with sodium compounds and fumes.
Hazardous Polymerization: Will not occur.

Toxicity Data: Not available.
Carcinogenicity: Not listed as carcinogen by IARC, ACGIH, OSHA and NTP.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to fish, daphnia, and other aquatic invertebrates: No data available.
Persistence and Degradability: Not available.
Mobility: Not available.
Results of PBT and vPvB assessment: No data available for assessment.

DOT (USA) & ADT/RID Europe: Not dangerous goods.
IMDG & IATA: Not dangerous goods.

USA Regulations:
SARA 311/312 Hazard Categories: Not hazardous. See section 2 for more 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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