Description

n-Nitrosodesipramine is a nitrosated derivative of the tricyclic antidepressant desipramine. This compound is of significant interest in pharmaceutical research and development, particularly in the study of drug metabolism, stability testing, and the formation of potentially genotoxic impurities. It serves as a critical reference standard and intermediate for analytical laboratories and R&D departments focused on ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Research: Essential for method development and validation in high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), and other analytical techniques targeting nitrosamines.
• Genotoxic Impurity (GTI) Studies: Employed in toxicological and regulatory research to understand the formation, fate, and control of nitrosamine impurities during drug synthesis and storage.
• Process Chemistry: Acts as a model compound or intermediate in research aimed at developing mitigation strategies to prevent nitrosamine formation in manufacturing processes.
• Quality Control & Assurance: Critical for in-house laboratory testing to comply with stringent global regulatory guidelines (e.g., FDA, EMA) on nitrosamine limits in pharmaceuticals.

Basic Information

Product Name	n-Nitrosodesipramine
CAS No.	57164-17-7
Molecular Formula	C18H21N3O
Molecular Weight	295.38 g/mol
Synonyms	N-Nitrosodesipramine; Desipramine Nitrosamine; 3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N-methyl-N-nitrosopropan-1-amine; N-Desmethylimipramine Nitrosamine; N-Nitroso Desipramine; Nitroso Desipramine; Desipramine, N-nitroso-; N-Nitroso-N-desmethylimipramine
EINECS	Contact for details

Quality Control

Every batch of n-Nitrosodesipramine is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that include data for identity, purity, and assay, typically determined by chromatographic methods (HPLC, GC) and spectroscopic techniques (NMR, MS). Our quality protocols are designed to meet the exacting standards required for reference materials in pharmaceutical impurity analysis and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is light-sensitive (store away from light). For long-term storage, consider conditions recommended for sensitive organic compounds.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content	≤ 0.5%
Residual Solvents	Meets ICH guidelines

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