Description

Paroxetine Related Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Paroxetine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Paroxetine API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Paroxetine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Pharmaceutical Research: Used in research settings to study the metabolism, synthesis pathways, and degradation mechanisms of Paroxetine.
• Quality Control (QC) Testing: Acts as a system suitability standard and a calibrant in routine QC testing of Paroxetine batches.

Basic Information

Item	Details
Product Name	Paroxetine Related Impurity 9
CAS No.	253768-88-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paroxetine Impurity 9; Paroxetine EP Impurity G; Paroxetine Related Compound G; 4-(4-Fluorophenyl)-3-[(3S,4R)-4-(4-fluorophenyl)-3-(hydroxymethyl)piperidin-1-yl]methylpiperidine; (3S,4R)-3-[(1,4-Bis(4-fluorophenyl)-1,4-diazepan-6-yl)methyl]-4-(hydroxymethyl)piperidine; Paroxetine Dimer Impurity; Paroxetine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Related Impurity 9 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with in-house specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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