Description

Paroxetine Impurity 46 is a high-purity 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 quality control testing. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Paroxetine API and finished dosage forms.
• Analytical Method Development: Used in HPLC, LC-MS, and other chromatographic methods to establish impurity profiles and retention times.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Paroxetine.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and synthesis impurities of Paroxetine.
• Pharmacopoeial Testing: Applied as a system suitability and identification standard in testing per USP, EP, or other pharmacopoeia monographs.

Basic Information

Product Name	Paroxetine Impurity 46
CAS No.	105813-07-8
Molecular Formula	C19H20FNO3
Molecular Weight	329.37 g/mol
Synonyms	Paroxetine Related Compound 46; Paroxetine EP Impurity G; (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine; 105813-07-8; Paroxetine Impurity G; Paroxetine Process Impurity; Fluoxetine analog impurity; Paroxetine isomer
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Impurity 46 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulated environments.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (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% w/w

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