Description

n-Nitrosodiethylamine-D10 is a stable isotope-labeled analog of the nitrosamine compound N-Nitrosodiethylamine (NDEA). This product is essential for use as an internal standard in analytical chemistry, enabling precise quantification and method validation. It is primarily required by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in trace-level analysis, regulatory compliance testing, and advanced research into nitrosamine impurities.

Application

• Internal Standard for LC-MS/MS: Critical for the accurate quantification of N-Nitrosodiethylamine (NDEA) in pharmaceutical products, food, and environmental samples.
• Method Development & Validation: Used to establish and validate highly sensitive analytical methods for nitrosamine detection in compliance with FDA, EMA, and ICH M7 guidelines.
• Metabolic and Toxicological Studies: Serves as a tracer in research investigating the metabolism, distribution, and carcinogenic mechanisms of nitrosamines.
• Quality Control & Assurance: Employed in routine QC labs to monitor for genotoxic nitrosamine impurities in active pharmaceutical ingredients (APIs), finished drug products, and consumer goods.
• Environmental Analysis: Applied in the analysis of nitrosamine contaminants in water, soil, and industrial waste streams.
• Forensic and Reference Standard: Acts as a certified reference material for confirming the identity of NDEA in complex matrices.

Basic Information

Product Name	n-Nitrosodiethylamine-D10
CAS No.	1219794-54-3
Molecular Formula	C4D10N2O
Molecular Weight	118.21 g/mol
Synonyms	NDEA-d10; N-Nitrosodiethylamine-d10; Diethylnitrosamine-d10; N-Nitroso-diethyl-d10-amine; Deuterated N-Nitrosodiethylamine; NDEA Internal Standard; N-Nitrosodi(ethyl-d5)amine; N-Nitrosobis(2,2,2,2',2',2'-d6-ethyl)amine
EINECS	Contact for details

Quality Control

Every batch of n-Nitrosodiethylamine-D10 is manufactured and analyzed under strict quality systems. We provide comprehensive Certificates of Analysis (COA) detailing isotopic purity, chemical purity, and solvent content, ensuring traceability and compliance with research and regulatory standards. Our quality commitment supports applications requiring high data integrity, such as pharmaceutical impurity testing and environmental monitoring.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. Due to its highly volatile nature, ensure containers are securely sealed and stored in a well-ventilated area. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture ingress and volatilization loss.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow liquid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98.0 atom % D
Chemical Purity (GC)	≥ 98.0%
Solvent Content (Residual Solvents)	Meets ICH guidelines

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