Specifications, Uses, SDS of Fexofenadine Hydrochloride Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Fexofenadine Hydrochloride or Fexofenadine HCl IP BP Ph Eur EP JP USP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 138452-21-8 or 153439-40-8.
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Muby Chem Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies of Fexofenadine Hydrochloride or Fexofenadine HCl IP BP Ph Eur EP JP 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, IP BP USP Ph Eur EP JP 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.

Fexofenadine Hydrochloride or Fexofenadine HCl Manufacturer Supplier Exporter

Fexofenadine Hydrochloride or Fexofenadine HCl CAS Number 138452-21-8 or 153439-40-8

The Properties, Specifications, Monograph and Uses of Fexofenadine Hydrochloride or Fexofenadine HCl:

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.

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.

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.

The MSDS-SDS Hazard Statement of Fexofenadine Hydrochloride or Fexofenadine HCl:

Fexofenadine Hydrochloride or Fexofenadine HCl SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 12-April-25

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.

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.

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: Fexofenadine Hydrochloride or Fexofenadine HCl.
CAS Number: 153439-40-8 or 138452-21-8
EINECS EC Code: 604-906-2

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.

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 as it can scatter the fire.
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.

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.).
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. Do not inhale vapors, mist, or gas. Avoid dust formation. Use a shovel to put the material into a convenient waste disposal container.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. 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 oxidizing agents. Storage: 2C to C. Preferably in freezer. Short term shipping may be ambient. Heat Sensitive.

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 low.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures low.
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.

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.

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.

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.

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 found for assessment.

Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.

DOT USA, TDG Canada & ADR/RID Europe: Not controlled.
IMDG/IMO & IATA/ICAO: Not controlled.

USA Regulations:
SARA 311/312 Hazard Categories: See section 2.
California Prop 65: Not listed to cause cancer, reproductive harm or birth defects.

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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Fexofenadine Hydrochloride or Fexofenadine HCl Manufacturers, Suppliers, Exporters, Wholesalers:

Plot No. 2900/46&47 + 2900/163to167, GIDC, Ankleshwar, Dist. Bharuch, India
India, USA, UAE
TEL: (Office) 91-22-23774610, 91-22-23723564

If I give you “My Word” Nobody can undo it.
If I sign an “Agreement” my Lawyer will undo it

Our products are for industrial and laboratory use only. The user must test the material before use. We are not dispensing chemists or druggist and do not offer over the counter type (OTC) products for medical use by individuals.

Specifications, Properties, Uses, SDS of Fexofenadine Hydrochloride or Fexofenadine HCl IP BP Ph Eur EP JP USP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 138452-21-8 or 153439-40-8.

Fexofenadine Hydrochloride or Fexofenadine HCl Manufacturers, Suppliers, Exporters, Wholesalers: