Description

Paroxetine Ep Impurity E is a specified impurity associated with the active pharmaceutical ingredient Paroxetine, an SSRI antidepressant. This compound is critical for pharmaceutical manufacturers and analytical laboratories for quality control and regulatory compliance purposes. It is primarily used as a certified reference standard in the development, validation, and routine testing of Paroxetine drug substances and finished products to ensure patient safety and product efficacy.

Application

• Primary use as a certified reference standard (CRS) for analytical method development and validation.
• Critical component in impurity profiling and stability studies of Paroxetine hydrochloride.
• Essential for pharmaceutical quality control (QC) and quality assurance (QA) laboratories to monitor impurity levels.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity thresholds and specifications.
• Supports research and development (R&D) of Paroxetine generics and related pharmaceutical compounds.
• Employed in pharmacopoeial testing to comply with EP, USP, or other international monographs.

Basic Information

Product Name	Paroxetine Ep Impurity E
CAS No.	105813-05-6
Molecular Formula	C19H20FNO3
Molecular Weight	329.37 g/mol
Synonyms	Paroxetine Impurity E; (-)-trans-4-(4'-Fluorophenyl)-3-[(3',4'-methylenedioxy)phenoxy]methylpiperidine; Paroxetine Related Compound E; Paroxetine EP Impurity E; 4-[(3,4-Methylenedioxyphenoxy)methyl]-4-(4-fluorophenyl)piperidine; UNII-7J3YML7J7F; Paroxetine Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial standards (EP, USP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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