Description

Paroxetine Maleate CAS NO 64006-44-6 is the maleate salt form of paroxetine, a potent and selective serotonin reuptake inhibitor (SSRI). This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and batch-to-batch consistency of finished pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of antidepressant medications.

Application

• Pharmaceutical API: The primary application is as the active ingredient in the manufacture of antidepressant tablets, capsules, and controlled-release formulations.
• Generic Drug Production: Serves as a key starting material for companies producing generic versions of paroxetine-based medications.
• Clinical Research: Used in preclinical and clinical studies for developing new therapeutic applications or novel drug delivery systems for SSRIs.
• Reference Standard: High-purity grades are employed as analytical reference standards in quality control laboratories for HPLC, UV, and other identification assays.
• Finished Dosage Formulation: Incorporated into final drug products designed for the treatment of major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, and social anxiety disorder.

Basic Information

Product Name	Paroxetine Maleate
CAS No.	64006-44-6
Molecular Formula	C23H23FNO5
Molecular Weight	412.43 g/mol
Synonyms	(-)-trans-4-(4'-Fluorophenyl)-3-[(3',4'-methylenedioxy)phenoxy]methyl]piperidine maleate; Paroxetine maleate salt; BRL 29060A; FG 7051 maleate; Paxil maleate (related to brand); Seroxat maleate (related to brand); (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine maleate
EINECS	Contact for details

Quality Control

Our Paroxetine Maleate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF Titration)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Rotation	-40.0° to -46.0° (c = 1 in methanol)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.