CAS Number 138452-21-8 or 153439-40-8, Fexofenadine HCl or Fexofenadine Hydrochloride USP IP BP Ph Eur JP EP Grade Manufacturers Exporters
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CAS Number 138452-21-8 or 153439-40-8, Fexofenadine HCl or Fexofenadine Hydrochloride USP IP BP Ph Eur JP EP Manufacturer Exporter
For Properties Specifications of Fexofenadine HCl or Fexofenadine Hydrochloride Click Properties, Specifications of Fexofenadine HCl or Fexofenadine Hydrochloride Manufacturer.
For Uses of Fexofenadine HCl or Fexofenadine Hydrochloride Click Uses of Fexofenadine HCl or Fexofenadine Hydrochloride Manufacturer.
For For SDS MSDS Sheet of Fexofenadine HCl or Fexofenadine Hydrochloride Click SDS Safety Data Sheet MSDS Sheet of Fexofenadine HCl or Fexofenadine Hydrochloride Manufacturer.
The Properties and Specifications of Fexofenadine HCl or Fexofenadine Hydrochloride:
Fexofenadine Hydrochloride USP Grade Specifications:
C32H39NO4-HCl --- 538.12
Benzeneacetic acid, 4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, hydrochloride, (±)-;
(±)-p-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidino]butyl]-α-methylhydratropic acid, hydrochloride 138452-21-8
UNII: 2S068B75ZU
DEFINITION
Fexofenadine Hydrochloride contains NLT 98.0% and NMT 102.0% of fexofenadine hydrochloride (C32H39NO4-HCl), calculated on the anhydrous basis.
IDENTIFICATION
A. Infrared Absorption
B. The retention time of the fexofenadine peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. Examine the precipitate formed in Other Components for the Content of Chloride test.
Acceptance criteria: A white precipitate is observed.
Content of Chloride: 6.45%–6.75% on the anhydrous basis.
Residue on Ignition: NMT 0.1%
Limit of Fexofenadine Related Compound B: To pass the test by chromatography.
Other Organic Impurities: To pass the test by chromatography.
Water Determination: NMT 2.0% for the anhydrous form; 6.0%–10.0% for the hydrate form. [Note— “Hydrate” refers to a mixture of dihydrate and trihydrate forms of fexofenadine hydrochloride.]
Packaging and Storage: Preserve in well-closed, light-resistant containers, and store at controlled room temperature.
Fexofenadine Hydrochloride BP Ph Eur Grade Specifications:
C32H40ClNO4 --- 538.1 CAS 153439-40-8
DEFINITION
2-[4-[(1RS)-1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid hydrochloride.
Content: 98.0 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, very slightly soluble in acetone.
It shows polymorphism.
IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Dissolve 30 mg of the substance to be examined in a mixture of equal volumes of methanol and water; sonicate if necessary and dilute to 2 mL with the same mixture of solvents. The solution gives reaction of chlorides.
TESTS
Impurity B: To pass the test by Liquid chromatography.
Related substances: To pass the test by Liquid chromatography.
Water: Maximum 0.5 per cent.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
We also manufacture Fexofenadine Hydrochloride EP IP JP grade.
The Uses of Fexofenadine HCl or Fexofenadine Hydrochloride:
Fexofenadine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine.
The MSDS-SDS Hazard Statement of Fexofenadine HCl or Fexofenadine Hydrochloride:
Fexofenadine Hydrochloride or Fexofenadine HCl SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 03-Nov-24
Section 1: Chemical Product and Company Identification
Product Name & Other Names: Fexofenadine Hydrochloride or Fexofenadine HCl.
CAS Number: 153439-40-8 or 138452-21-8
EINECS EC Code: 604-906-2
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
Section 2: Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)
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.
Labeling Regulation as per GHS & EC 1272/2008 (CLP) & GHS
GHS Label Elements NONE |
Signal Word: None
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.
Section 3: Composition and Information on Ingredients
Product Name & Other Names: Fexofenadine Hydrochloride or Fexofenadine HCl.
CAS Number: 153439-40-8 or 138452-21-8
EINECS EC Code: 604-906-2
Section 4: First Aid Measures
Always seek medical advice after the first aid treatment.
Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.
Section 5: Fire and Explosion Data
Fire: Not a fire hazard. However, it can burn at high temperature.
Products of Combustion: Fumes and Oxides of Carbon and Nitrogen. Hydrogen chloride and complex chlorine compounds may also evolve.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Wear self-contained breathing apparatus for firefighting if necessary. Avoid solid water jet.
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:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container.
Large Spill: Contain spilled material. Do not inhale vapors, mist, or gas. Avoid dust formation. Use a shovel to put the material into a convenient waste disposal container.
Section 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.). 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 agents. Storage: 2C to C. Preferably in freezer. Heat Sensitive.
Section 8: Exposure Controls/Personal Protection
Occupational Exposure Limits: This product, as supplied, does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits.
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.
Section 9: Physical and Chemical Properties
Physical state and appearance: White or almost white, crystalline powder.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: No data found.
Melting point/freezing point: 148C to 150C. literature.
Initial boiling point and boiling range: 697C predicted.
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: Soluble in methanol.
Viscosity: No data found.
Molecular Formula: C32H39NO4-HCl
Molecular Weight: 538.12
Section 10: Stability and Reactivity Data
Stability: It is stable at recommended storage temperature closed containers under normal storage & handling.
Hazardous decomposition products: Fumes and Oxides of Carbon and Nitrogen. Hydrogen chloride and complex chlorine compounds may also evolve
Conditions of instability: Incompatible materials, heat flame.
Incompatibility with various substances: Avoid high temperatures, sparks, open flames, and moisture. Avoid contact with strong oxidizing agents.
Polymerization: Will not occur.
Section 11: Toxicological Information
LD50 Oral – Rat: No data found.
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.
Section 12: Ecological Information
Toxicity to fish: No data found.
Persistence and Degradability: Unlikely to persist.
Mobility: Likely to be mobile.
Bioaccumulation/ Accumulation: Degradable.
Results of PBT and vPvB assessment: No data available for assessment.
Section 13: Disposal Considerations
Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.
Section 14: Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IMDG/IMO & IATA/ICAO: Not regulated.
Section 15: Other Regulatory Information
USA Regulations:
SARA 311/312 Hazard Categories: See section 2.
California Prop 65: None of the chemicals in this product are listed.
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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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.
Fexofenadine HCl or Fexofenadine Hydrochloride Structure
CAS Number 138452-21-8 or 153439-40-8, Fexofenadine HCl or Fexofenadine 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. 11-dec-24
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