Paroxetine HCl or Paroxetine Hydrochloride Anhydrous Hemihydrate USP BP Ph Eur EP IP Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Paroxetine HCl or Paroxetine Hydrochloride Anhydrous Hemihydrate USP BP Ph Eur EP IP, 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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Paroxetine HCl or Paroxetine Hydrochloride CAS Number 78246-49-8 or 130855-16-2 or 110429-35-1, EINECS EC Number: 600-962-7, Molecular Formula: C19H21ClFNO3, Molecular Weight: 365.82 for anhydrous, HS Code 29339900 or 29349900 or 38229010

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Paroxetine HCl or Paroxetine Hydrochloride.

Paroxetine Hydrochloride USP Grade Specifications:
C19H20FNO3-HCl --- 365.83
Hemihydrate --- 374.83
Piperidine, 3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-, hydrochloride, (3S -trans)-;
(−)-(3S ,4R )-4-(p-Fluorophenyl)-3-[[(3,4-methylenedioxy)phenoxy]methyl]piperidine hydrochloride
CAS 78246-49-8
UNII: 3I3T11UD2S

DEFINITION
Paroxetine Hydrochloride is anhydrous or contains one-half molecule of water of hydration. It contains NLT 98.5% and NMT 102.0% of paroxetine hydrochloride (C19H20FNO3-HCl), calculated on the anhydrous and solvent-free basis.

IDENTIFICATION
A. Infrared Absorption.
B. Identification Tests—General, Chloride.

Residue on Ignition: NMT 0.1%
Limit of Paroxetine Related Compound C: To pass the test by chromatography.
Limit of 1-Methyl-4-(p-fluorophenyl)-1,2,3,6-tetrahydropyridine: To pass the test by chromatography.
Organic Impurities, Procedure 1: To pass the test by chromatography.
Organic Impurities, Procedure 2: To pass the test by chromatography.
Water Determination: NMT 1.5% for the anhydrous form; 2.2%–2.8% for the hemihydrate form.
Packaging and Storage: Preserve the anhydrous form in tight containers. Preserve the hemihydrate form in well-closed containers. Store at controlled room temperature.

Paroxetine Hydrochloride BP Ph Eur Grade:
Anhydrous Paroxetine Hydrochloride
C19H21ClFNO3 --- 365.8 CAS 78246-49-8
Action and use: Selective serotonin reuptake inhibitor; antidepressant.

DEFINITION
(3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride.
Content: 97.5 per cent to 102.0 per cent (anhydrous substance).

PRODUCTION
Impurity G: Maximum 1 ppm, determined by a suitable validated method.

CHARACTERS
Appearance: White or almost white, hygroscopic, crystalline powder.
Solubility: Slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol and in methylene chloride. It shows polymorphism.

IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Water.
C. It gives reaction of chlorides.

TESTS
Impurity D: To pass the test by liquid chromatography.
Related substances: To pass the test by liquid chromatography.
Impurities H and I: To pass the test by liquid chromatography.
Acetone: Maximum 3.5 per cent.
2-Propanol: Maximum 4.3 per cent.
Water: Maximum 1.5 per cent, determined on 0.500 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 ;g in a platinum crucible.
Storage: In an airtight container, at a temperature not exceeding 25C.

Paroxetine Hydrochloride Hemihydrate BP Ph Eur Grade Specifications:
C19H21ClFNO3,½H2O --- 374.8 ---110429-35-1
Action and use: Selective serotonin reuptake inhibitor; antidepressant.

DEFINITION
(3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride hemihydrate.
Content: 97.5 per cent to 102.0 per cent (anhydrous substance).

PRODUCTION
Impurity G: Maximum 1 ppm, determined by a suitable, validated method.

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol (96 per cent) and in methylene chloride. It shows pseudopolymorphism.

IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Examine the chromatograms.
C. Water.
D. It gives reaction (b) of chlorides.

Impurity D: To pass the test by liquid chromatography.
Related substances: To pass the test by liquid chromatography.
Water: 2.2 per cent to 2.7 per cent, determined on 0.300 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g in a platinum crucible.
Storage: Protected from light.

We manufacture Paroxetine Hydrochloride or Paroxetine HCl Anhydrous and Hemihydrate BP Ph Eur IP EP USP 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.

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)

Exporters to USA Canada UAE Europe South Africa Tanzania Kenya Uganda Egypt Nigeria Turkey Mexico Brazil Argentina Chile Dubai etc.

Global or International Suppliers, Exporters, Importers, Manufacturers

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Paroxetine Hydrochloride or Paroxetine HCl Anhydrous Hemihydrate
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 20-Sept-24

Product Name & Other Names: 78246-49-8 or 130855-16-2 or 110429-35-1.
CAS Number: 2277-92-1
EINECS EC Number: 600-962-7
Molecular Formula: C19H21ClFNO3
Molecular Weight: 365.82 for anhydrous material.
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

Acute toxicity, Oral Category 4 - H302
Skin sensitization Category 1 - H317
Eye irritation Category 2 - H319
Specific target organ toxicity - single exposure (Category 3) Respiratory system - H335
Hazardous to the aquatic environment - Chronic Hazard, Category 1- H410

Hazard Statements:
H302: Harmful if swallowed.
H317: May cause an allergic skin reaction.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
H410: Very toxic to aquatic life with long lasting effects.

Precautionary Statements:
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.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P314: Get medical advice/attention if you feel unwell.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
P360: Rinse immediately contaminated clothing and skin with plenty of water before removing clothes.
P403 P404: Store in well-ventilated place. Keep container tightly closed.
P501: Dispose of contents/container in accordance with local/national regulation.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xn Harmful
Xi Irritant
N Dangerous for the environment.
Risk Phrase:
R22 Harmful if swallowed.
R36/37/38 - Irritating to eyes, respiratory system and skin.
R43 May cause sensitization by skin contact.
R50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Product Name & Other Names: 78246-49-8 or 130855-16-2 or 110429-35-1.
CAS Number: 2277-92-1
EINECS EC Number: 600-962-7

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.

General Hazards: Contact with the eyes causes immediate severe irritation of the eye and eyelids. Product will support combustion.
Extinguishing Media: Carbon dioxide, dry chemical, chemical foam water fog. Do not use a heavy water stream. Keep containers cool by spraying with water. Use extinguishing media appropriate for surrounding fire.
Fire & Explosion Hazard: May evolve oxides of carbon, oxides of nitrogen, chlorine & fluorine compounds, and fumes 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!
Unusual Fire and Explosion Hazards: Closed containers can explode due to buildup of pressure when exposed to extreme heat.
Hazardous Combustion Products: Products of combustion include smoke, toxic fumes, oxides of carbon, nitrogen, chlorine & fluorine compounds.

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 sewer, 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. It will support combustion. For large spills, confine spill, soak up with approved absorbent, shovel product into approved container for disposal.

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 strong oxidizing agents. Keep containers closed when not in use; protect containers from abuse; protect from extreme temperatures, open flames. This material will support combustion. Storage: Store at room temperature. Preferably refrigerate. Short term shipping may be ambient.

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 listed.
Personal Protection: Respiratory Protection (Specify Type): None required while threshold limits are kept below maximum allowable concentrations; if TWA exceeds standard workplace limits, NIOSH approved respirator must be worn.
Hand Protection: Neoprene, butyl or nitrile rubber gloves with cuffs.
Eye Protection: Chemical safety goggles.
Other Protective Clothing Or Equipment: Apron, or other equipment should be worn to prevent skin contact, safety eyewash station nearby. Practice safe workplace habits. Minimize body contact with this, as well as all chemicals in general.

Appearance: White or almost white, hygroscopic, crystalline powder.
Odor: Not available
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting point/freezing point: 137C to 139C literature.
Boiling Point: 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 (MM Hg): Not available.
Vapor Density (Air = 1) : Not available.
Evaporation Rate (water = 1): Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Insoluble in water. Soluble in DMSO (25 mg/ml), chloroform, and methanol.
Viscosity: Not available.
Molecular Formula: C19H21ClFNO3
Molecular Weight: 365.82 for anhydrous material.

Stability: Stable at normal temperatures and operating conditions.
Conditions to Avoid: Avoid excessively high temperatures and contact with strong oxidizing agents. Direct sunlight. Air contact.
Incompatibilities: Strong oxidizing agents.
Decomposition: Decomposition yields carbon oxides, chlorine & fluorine compounds, nitrogen oxides and fumes.
Polymerization: Polymerization will not occur.

Acute toxicity:
Acute toxicity estimate Oral – 500.1 mg/kg.
Carcinogenicity: No ingredient of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC, NIT, ACGIH or OSHA.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to daphnia and other aquatic invertebrates: static test EC50 - Daphnia magna (Water flea) - 6,24 mg/l - 48 h.
Persistence and Degradability: Not available.
Mobility: Not available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Dispose of it in accordance with Local, State, and Federal Regulations. Consult local, state, or Federal Environmental Protection Agency before disposing of any chemicals.

DOT USA, TDG Canada & ADR/RID Europe:
UN number: 3077
Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (Paroxetine hydrochloride).
Hazard class(es) 9; Packing group: III.
IMDG/IMO:
UN number: 3077
Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (Paroxetine hydrochloride).
Hazard class(es) 9; Packing group: III.
ICAO/IATA:
UN number: 3077
Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (Paroxetine hydrochloride).
Hazard class(es) 9; Packing group: III.

European Labeling in Accordance with EC Directives:
H302: Harmful if swallowed.
H317 May cause an allergic skin reaction.
H319 Causes serious eye irritation.
H335 May cause respiratory irritation.
H410 Very toxic to aquatic life with long lasting effects.

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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