Description

n-Nitroso Paroxetine Impurity Q is a specific nitrosamine impurity related to the active pharmaceutical ingredient (API) Paroxetine. This compound is critical for pharmaceutical development and quality control, as regulatory bodies mandate strict monitoring and control of nitrosamine impurities in drug substances and products due to their potential genotoxic risk. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory affairs professionals for method development, validation, and ensuring drug safety and compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Paroxetine and its related substances.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS/MS, to detect and quantify nitrosamine impurities.
• Quality Control & Assurance: Employed in routine QC testing of Paroxetine API and finished drug products to ensure compliance with stringent regulatory limits for nitrosamines.
• Regulatory Submission and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity profiles and control strategies.
• Stability Studies: Used to monitor the formation and levels of this impurity throughout the shelf-life of pharmaceutical products.
• Research and Development: Facilitates research into the formation, fate, and mitigation of nitrosamine impurities during drug synthesis and manufacturing processes.

Basic Information

Product Name	n-Nitroso Paroxetine Impurity Q
CAS No.	2361294-43-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paroxetine Nitrosamine Impurity Q; N-Nitroso Paroxetine; Nitrosamine Impurity of Paroxetine; Paroxetine Related Compound Q; (3S,4R)-3-((1,3-Benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-1-nitrosopiperidine; 1-Nitroso-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine
EINECS	Contact for details

Quality Control

Our n-Nitroso Paroxetine Impurity Q is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC and LC-MS/MS, to ensure high purity and accurate characterization. A comprehensive Certificate of Analysis (COA) is provided, detailing identity, purity, and impurity profiles. Our quality commitment aligns with ICH guidelines and supports compliance in regulated pharmaceutical markets.

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 (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report and comply with individual limits
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.