CAS Number 78246-49-8 or 130855-16-2 or 110429-35-1, Paroxetine HCl or Paroxetine Hydrochloride IP BP Ph Eur EP USP Grade Manufacturers Exporters
------ 
CAS Number 78246-49-8 or 130855-16-2 or 110429-35-1, Paroxetine HCl or Paroxetine Hydrochloride IP BP Ph Eur EP USP Manufacturer Exporter
For Properties Specifications of Paroxetine HCl or Paroxetine Hydrochloride Click Properties, Specifications of Paroxetine HCl or Paroxetine Hydrochloride Manufacturer.
For Uses of Paroxetine HCl or Paroxetine Hydrochloride Click Uses of Paroxetine HCl or Paroxetine Hydrochloride Manufacturer.
For For SDS MSDS Sheet of Paroxetine HCl or Paroxetine Hydrochloride Click SDS Safety Data Sheet MSDS Sheet of Paroxetine HCl or Paroxetine Hydrochloride Manufacturer.
The Properties and Specifications of 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 also supply Paroxetine Hydrochloride or Paroxetine HCl Anhydrous and Hemihydrate as per IP EP Grade.
The Uses of Paroxetine HCl or Paroxetine Hydrochloride:
Paroxetine Hydrochloride or Paroxetine HCl is an antidepressant drug. It is used as an antidepressant, an anxiolytic drug, a hepatotoxic agent, a P450 inhibitor and a serotonin uptake inhibitor.
The MSDS-SDS Hazard Statement of Paroxetine HCl or Paroxetine Hydrochloride:
Paroxetine Hydrochloride or Paroxetine HCl Anhydrous Hemihydrate
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 15-Nov-24
1. Product Identification
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
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
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
Labeling according to GHS USA & Regulation (EC) No 1272/2008
GHS Label Elements  Irritant Harmful |
GHS Label Elements |
Signal Words: Danger
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.
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.
3. Composition/Information on Ingredients
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
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
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
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 as it can scatter the fire. 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.
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.
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).
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.
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).
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 strong oxidizing agents. Keep containers closed when not in use; protect containers from abuse; protect from extreme temperatures, open flames. Storage: Store 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.
Exposure Limits: Not listed.
Personal Protection: Respiratory Protection (Specify Type): None required while threshold limits are kept below maximum allowable concentrations.
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.
9. Physical and Chemical Properties
Appearance: White or almost white, hygroscopic, crystalline powder.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: No data found.
Melting point/freezing point: 137C to 139C literature.
Boiling Point: 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 (MM Hg): No data found.
Vapor Density (Air = 1) : No data found.
Evaporation Rate (water = 1): No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Insoluble in water. Soluble in DMSO (25 mg/ml), chloroform, and methanol.
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. 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.
11. Toxicological Information
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: No data found.
Teratogenic Effects: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.
12. Ecological Information
Toxicity to daphnia and other aquatic invertebrates: static test EC50 - Daphnia magna (Water flea) - 6,24 mg/l - 48 h.
Persistence and Degradability: No data found.
Mobility: No data found.
Bioaccumulation/ Accumulation: No data found.
Results of PBT and vPvB assessment: No data found. for assessment.
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. Follow all the pollution control laws.
14. Transport Information
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.
15. Regulatory Information
No more data is found.
Section 16 - Additional Information
DISCLAIMER: The information and recommendations set forth herein 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.
Paroxetine HCl or Paroxetine Hydrochloride Structure
CAS Number 78246-49-8 or 130855-16-2 or 110429-35-1, Paroxetine HCl or Paroxetine 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
We manufacture:
Chlorhexidine Hydrochloride or Chlorhexidine Dihydrochloride or Chlorhexidine
Esmolol Hydrochloride or Esmolol HCl
Fexofenadine HCl or Fexofenadine Hydrochloride
Fingolimod Hydrochloride or Fingolimod HCl
Nebivolol Hydrochloride or Nebivolol HCl
Paroxetine HCl or Paroxetine Hydrochloride
Phenazopyridine Hydrochloride or Phenazopyridine HCl
Pioglitazone Hydrochloride or Pioglitazone HCl