CAS Number 162359-56-0, Fingolimod Hydrochloride or Fingolimod HCl USP IP BP Ph Eur EP Grade Manufacturers Exporters
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CAS Number 162359-56-0, Fingolimod Hydrochloride or Fingolimod HCl USP IP BP Ph Eur EP Manufacturer Exporter
For Properties Specifications of Fingolimod Hydrochloride or Fingolimod HCl Click Properties, Specifications of Fingolimod Hydrochloride Manufacturer.
For Uses of Fingolimod Hydrochloride or Fingolimod HCl Click Uses of Fingolimod Hydrochloride or Fingolimod HCl Manufacturer.
For For SDS MSDS Sheet of Fingolimod Hydrochloride Click SDS Safety Data Sheet MSDS Sheet of Fingolimod Hydrochloride Manufacturer.
The Properties and Specifications of Fingolimod Hydrochloride or Fingolimod HCl:
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.
We manufacture Fingolimod Hydrochloride or Fingolimod HCl BP Ph Eur EP IP USP Grade.
The Uses of Fingolimod Hydrochloride or Fingolimod HCl:
Fingolimod Hydrochloride or Fingolimod HCl is used in the treatment of multiple sclerosis.
The MSDS-SDS Hazard Statement of Fingolimod Hydrochloride or Fingolimod HCl:
Fingolimod Hydrochloride or Fingolimod HCl SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 16-Nov-24
1. Product Identification
Product Name & Other Names: Fingolimod Hydrochloride or Fingolimod HCl.
CAS Number: 162359-56-0
EINECS EC Number: 680-631-1
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 Problem |
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.
P270: Do not eat, drink or smoke when using this product.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
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.
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.
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.
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 scatter 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.
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.
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.).
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.).
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 oxidizing agent. Storage: Preferably refrigerate. Heat Sensitive.
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.
Exposure Limits: Not established.
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. Wash hands after handling.
9. Physical and Chemical Properties
Appearance: White to almost white powder or crystals.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: No data found.
Melting/Freezing Point: 110C literature.
Initial boiling point and boiling range: No data found.
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 in Water: Soluble in water. Soluble in DMSO.
Viscosity: No data found.
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: No data found.
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 No data found.
Results of PBT and vPvB assessment: No No data found.
Persistence and degradability: No data found.
Mobility in soil: No data found.
Bioaccumulative potential: No data found.
Mobility: No data found.
13. Disposal Considerations
Dispose of it in accordance with Local, State, and Federal Regulations. Follow all the pollution control rules.
14. Transport Information
DOT USA & ADR/RID Europe: Not dangerous goods.
IATA & IMDG: Not dangerous goods.
15. Regulatory Information
No additional data is found.
Section 16 - Additional Information
DISCLAIMER: The information and recommendations set forth are presented in good faith and believed correct as of the date hereof. It is compiled from various sources, and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules, or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a professionally trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.
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.
Fingolimod Hydrochloride or Fingolimod HCl Structure
CAS Number 162359-56-0 Fingolimod Hydrochloride Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 18-nov-24
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