Description

Paroxetine Impurity 5 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Paroxetine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Paroxetine-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Paroxetine Impurity 5 in Paroxetine API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Paroxetine.
• Quality Control and Batch Release: Employed in routine QC testing to ensure that Paroxetine API and drug products meet stringent pharmacopeial (e.g., USP, EP) specifications for impurity profiles.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to health authorities like the FDA and EMA.
• Research and Development: Supports impurity isolation, characterization, and toxicological studies during the drug development lifecycle.

Basic Information

Product Name	Paroxetine Impurity 5
CAS No.	100332-20-5
Molecular Formula	C19H20FNO3
Molecular Weight	329.37 g/mol
Synonyms	Paroxetine Related Compound 5; Paroxetine EP Impurity 5; Paroxetine USP Impurity 5; (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine; 3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine; 4-(4-Fluorophenyl)-3-[(1,3-benzodioxol-5-yloxy)methyl]piperidine; Paroxetine Impurity F (in some references)
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (e.g., HPLC, NMR, MS) to ensure they meet the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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