Description

Paroxetine Ep Impurity G is a high-purity reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Paroxetine. This compound is critical for ensuring the quality, safety, and efficacy of Paroxetine-based drug products by serving as a known impurity for identification and quantification. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and regulatory bodies involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Paroxetine Ep Impurity G in API and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Paroxetine.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Supports synthetic route optimization and process chemistry studies aimed at minimizing the formation of this impurity during API manufacturing.

Basic Information

Product Name	Paroxetine Ep Impurity G
CAS No.	69675-10-1
Molecular Formula	C19H20FNO3
Molecular Weight	329.37 g/mol
Synonyms	Paroxetine Impurity G; Paroxetine Related Compound G; (-)-trans-4-(4'-Fluorophenyl)-3-[[3',4'-(methylenedioxy)phenoxy]methyl]piperidine; (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine; Paroxetine EP Impurity G; Paroxetine USP Impurity G; Paroxetine Process Impurity G
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

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); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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