Fingolimod Hydrochloride or Fingolimod HCl USP EP IP BP Ph Eur Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Fingolimod Hydrochloride or Fingolimod HCl USP EP IP BP Ph Eur, 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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Fingolimod HCl or Fingolimod Hydrochloride CAS Number 162359-56-0, EINECS EC Number: 680-631-1, Molecular Formula: C19H34ClNO2 or C19H33NO2-HCl, Molecular Weight: 343.93, HS Code 29221900
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SDS MSDS Sheet of Fingolimod HCl or Fingolimod Hydrochloride Manufacturers
Fingolimod Hydrochloride
Fingolimod HCl USP EP IP BP Ph Eur Suppliers
Fingolimod Hydrochloride USP NF Grade Specifications:
C19H33NO2-HCl --- 343.93
1,3-Propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, hydrochloride;
2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride CAS 162359-56-0
Fingolimod (free base) C19H33NO2 --- 307.48 CAS 162359-55-9
DEFINITION
Fingolimod Hydrochloride contains NLT 98.0% and NMT 102.0% of fingolimod hydrochloride (C19H33NO2- HCl), calculated on anhydrous and solvent-free basis.
IDENTIFICATION
A. Spectroscopic Identification Tests, Infrared Spectroscopy.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay by chromatography.
C. Identification Tests—General Chemical Identification Tests, Chloride.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by chromatography.
Water Determination: NMT 0.5%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count is NMT 1000 cfu/g. Thetotal combined molds and yeasts count is NMT 100 cfu/g.
Packaging and Storage: Preserve in well-closed containers. Store below 30C in a dry place.
We manufacture Fingolimod Hydrochloride or Fingolimod HCl IP USP BP Ph Eur 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:
Fingolimod HCl or Fingolimod Hydrochloride
Nebivolol Hydrochloride or Narbivolol
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30
e-mail: info@mubychem.com
USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)
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Last
22 September, 2024
Exporters to USA Canada UAE Europe South Africa Tanzania Kenya Uganda Egypt Nigeria Turkey Mexico Brazil Argentina Chile Dubai etc.
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Fingolimod Hydrochloride or Fingolimod HCl SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 22-Sept-24
1. Product Identification
Product Name & Other Names: Fingolimod Hydrochloride or Fingolimod HCl.
CAS Number: 162359-56-0
EINECS EC Number: 680-631-1
Molecular Formula: C19H34ClNO2 or C19H33NO2-HCl
Molecular Weight: 343.93
Intended Use: Industrial Manufacturing.
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
Reproductive toxicity Category 2, H361
Labeling according to GHS USA & Regulation (EC) No 1272/2008
GHS Label Elements  Health Hazard |
Signal Words: Danger
Hazard Statements:
H361: Suspected of damaging fertility or the unborn child.
Precautionary Statements:
P202: Do not handle until all safety precautions have been read and understood.
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contaminated parts thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P314: Get medical advice/attention if you feel unwell.
P302+352: IF ON SKIN: Wash with plenty of soap and water.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn Harmful
Risk Phrases:
R61 May cause harm to the unborn child.
3. Composition/Information on Ingredients
Product Name & Other Names: Fingolimod Hydrochloride or Fingolimod HCl.
CAS Number: 162359-56-0
EINECS EC Number: 680-631-1
Molecular Formula: C19H34ClNO2 or C19H33NO2-HCl
4. First Aid Measures
Inhalation: Remove affected person to fresh air; if normal breathing has not returned within a few minutes after exposure, get medical attention.
Skin: Remove contaminated clothing; wash affected area with soap and water; launder contaminated clothing before reuse. Seek medical attention.
Eyes: Immediately, flush eyes for 15 minutes in clear running water while holding eyelids open; seek medical attention immediately.
Ingestion: Drink two glasses of water followed by milk, milk of magnesia or other non-alcoholic liquids; Do not induce vomiting; seek medical attention immediately.
Physician may treat symptomatically.
5. Fire Fighting Measures
Flammable Limits: No unusual fire or explosion hazards noted. However, it will burn at high temperature.
General Hazards: Contact with eyes causes immediate severe irritation of the eye and eyelids. Product will support combustion.
Extinguishing Media: Carbon dioxide, water fog, dry chemical, chemical foam.
Organics solids, may be ignitable. Keep containers cool by spraying with water. Use extinguishing media appropriate for surrounding fire. Avoid solid water jet as it may spread the fire.
Fire & Explosion Hazard: May evolve toxic fumes, oxides of carbon (COx), oxides of nitrogen (NOx) and chlorine compounds under fire conditions.
In case of fire, wear a full face positive-pressure self-contained breathing apparatus and protective suit. Self - contained respiratory equipment; cool containers to prevent pressure buildup and explosion when exposed to extreme heat. Caution - material will support combustion!
Hazardous Combustion Products: Products of combustion include smoke, toxic fumes, oxides of carbon to include carbon monoxide, nitrogen oxides and chlorine compounds.
Specific Methods: Cool containers exposed to flames with water until well after the fire is out.
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: It may support combustion. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. 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.
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. Provide appropriate exhaust ventilation at places where dust is formed. 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 oxidizing agent. Keep this and other chemicals out of reach of children. Storage: Preferably refrigerate. OK to freeze. Heat Sensitive. Shipping may be at room temperature.
8. Exposure Controls/Personal Protection
Engineering Controls: The use of local exhaust ventilation is recommended to control emissions near the source. Provide mechanical ventilation of confined spaces. Use corrosion-resistant, explosion-proof ventilation equipment.
Exposure Limits: Not established.
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 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.
9. Physical and Chemical Properties
Appearance: White to almost white powder or crystals.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting/Freezing Point: 110C 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 in Water: Soluble in water. Soluble in DMSO.
Viscosity: Not available.
Molecular Formula: C19H34ClNO2 or C19H33NO2-HCl
Molecular Weight: 343.93
10. Stability and Reactivity
Stability: Stable at normal temperatures and operating conditions.
Conditions to Avoid: Avoid excessively high temperatures and contact with strong oxidizing agents.
Incompatibilities: Oxidizing Agent.
Decomposition: Decomposition yields toxic fumes, oxides of carbon (COx), oxides of nitrogen (NOx) and chlorine compounds.
Polymerization: Polymerization will not occur.
11. Toxicological Information
Toxicity Data: Not available
Reproduction: Suspected of damaging fertility or the unborn child.
Carcinogenicity: Not listed as a human carcinogen by OSHA, IARC, ACGIH & NTP.
12. Ecological Information
Toxicity to fish: No data available.
Results of PBT and vPvB assessment: No data available.
Persistence and degradability: No data available.
Mobility in soil: No data available.
Bioaccumulative potential: No data available.
Mobility: No data available
13. Disposal Considerations
Dispose of it in accordance with Local, State, and Federal Regulations. Consult local, state, or Federal Environmental Protection Agency before disposing of any chemicals.
14. Transport Information
DOT USA & ADR/RID Europe: Not regulated.
IATA & IMDG: Not regulated.
15. Regulatory Information
No significant information is available.
Section 16 - Additional Information
European Labeling in Accordance with EC Directives:
H361: Suspected of damaging fertility or the unborn child.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn Harmful
Risk Phrases:
R61 May cause harm to the unborn child.
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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