Description

n-Nitroso Venlafaxine Ep Impurity D is a specialized nitrosamine impurity critical for analytical reference and pharmaceutical quality control. This compound is essential for the development and validation of sensitive analytical methods to monitor and control genotoxic impurities in Venlafaxine and its related drug substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals engaged in ensuring drug safety and compliance with stringent international guidelines for nitrosamine limits.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the quantitative and qualitative analysis of nitrosamine impurities in Venlafaxine Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Method Development and Validation: Used in developing, optimizing, and validating chromatographic methods (e.g., LC-MS/MS, GC-MS) for trace-level detection of nitrosamines.
• Quality Control and Batch Release: Employed as a system suitability standard and for preparing calibration curves in routine QC testing to ensure batches comply with regulatory thresholds (e.g., AI limits set by FDA, EMA).
• Stability Studies: Utilized to assess the potential formation of nitrosamine impurities in drug products over time under various storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control strategies for potential genotoxic impurities.
• Research and Development: Supports investigative studies into the formation, fate, and mitigation of nitrosamine impurities during synthetic processes.

Basic Information

Product Name	n-Nitroso Venlafaxine Ep Impurity D
CAS No.	2680662-11-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Venlafaxine Nitrosamine Impurity D; N-Nitroso Venlafaxine EP Impurity D; Venlafaxine N-Nitroso Impurity; Nitrosamine Impurity of Venlafaxine; NDMA Analog for Venlafaxine; Venlafaxine Related Compound D (Nitrosamine); 2680662-11-5; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of n-Nitroso Venlafaxine Ep Impurity D is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure traceability and reliability for your critical analytical work. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under 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 COA
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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