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Paroxetine Hydrochloride or Paroxetine HCl Anhydrous Hemihydrate BP Ph EP Eur USP IP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Paroxetine Hydrochloride or Paroxetine HCl Anhydrous Hemihydrate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.

We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.

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Paroxetine Hydrochloride or Paroxetine HCl Anhydrous Hemihydrate SDS of Manufacturers

Paroxetine Hydrochloride or Paroxetine Manufacturers

Synonyms: Paroxetine Hydrochloride or Paroxetine HCl Anhydrous Hemihydrate
CAS Number: 78246-49-8 or 130855-16-2 or 110429-35-1, Molecular Weight: 365.82 for anhydrous material., Chemical Formula: C19H21ClFNO3, EINECS EC Number: 600-962-7, FEMA: ----,

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. Paroxetine Hydrochloride is also available as it’s hemihydrate.

General Properties and Specifications of Paroxetine Hydrochloride or Paroxetine HCl:

Synonyms: Piperidine,3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-,hydrochloride,(3S,4R) or (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine hydrochloride.
Appearance: White or almost white, hygroscopic, crystalline powder.
Assay: 98%
Melting Point: 137C to 139C literature.
Solubility: Insoluble in water. Soluble in DMSO (25 mg/ml), chloroform, and methanol.
Storage: Store at room temperature. Preferably refrigerate. Short term shipping may be ambient.


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.

Keywords: Paroxetine Hydrochloride or Paroxetine HCl Anhydrous Hemihydrate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 78246-49-8 or 130855-16-2 or 110429-35-1 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

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ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

e-mail: info@anmol.org

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Last updated 12-sep-24

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Paroxetine Hydrochloride
Paroxetine HCl BP Ph EP Eur USP IP Grades Manufacturers
Paroxetine Hydrochloride or Paroxetine