Description

Paroxetine Impurity 35 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Paroxetine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Paroxetine API and finished dosage forms.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submissions (e.g., for FDA, EMA) by providing definitive impurity identification data.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Paroxetine under various stress conditions.
• Research & Development: Serves as a key intermediate or impurity in synthetic chemistry research and process optimization for Paroxetine.
• Pharmacopoeial Testing: Used to comply with testing requirements specified in pharmacopoeias such as USP, EP, and BP.

Basic Information

Product Name	Paroxetine Impurity 35
CAS No.	33842-14-7
Molecular Formula	C19H20FNO3
Molecular Weight	329.37 g/mol
Synonyms	(-)-trans-4-(4-Fluorophenyl)-3-[[3,4-(methylenedioxy)phenoxy]methyl]piperidine; Paroxetine Related Compound B; Paroxetine Impurity B; Paroxetine EP Impurity B; 4-(4-Fluorophenyl)-3-[(1,3-benzodioxol-5-yloxy)methyl]piperidine; (3S,4R)-4-(4-Fluorophenyl)-3-[(1,3-benzodioxol-5-yloxy)methyl]piperidine; UNII-8V0T60D2QN
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Impurity 35 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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