Description

n-Nitrosodimethyl-1,1,1-D3-Amine is a deuterated isotopologue of the well-known nitrosamine, N-Nitrosodimethylamine (NDMA). This compound is of significant value as a stable isotope-labeled internal standard for precise analytical quantification. It is essential for researchers and quality control laboratories requiring high-accuracy trace analysis in complex matrices. Primary applications include method development and validation in pharmaceutical impurity testing, environmental monitoring, and food safety analysis to ensure regulatory compliance and product safety.

Application

• Pharmaceutical Impurity Analysis: Serves as a critical internal standard for the accurate quantification of genotoxic nitrosamine impurities (e.g., NDMA) in active pharmaceutical ingredients (APIs) and finished drug products, supporting compliance with FDA, EMA, and ICH M7 guidelines.
• Environmental and Water Testing: Used in isotope dilution methods for the ultra-trace detection of nitrosamines in drinking water, wastewater, and industrial effluents.
• Food and Beverage Safety: Employed in analytical methods to monitor and quantify nitrosamine levels in processed foods, cured meats, and alcoholic beverages.
• Forensic and Toxicological Research: Acts as a reference standard in metabolic studies, toxicokinetics, and forensic investigations involving nitrosamine exposure.
• Method Development and Validation: Provides a stable, non-interfering isotopic marker to establish specificity, accuracy, and precision in LC-MS/MS and GC-MS methodologies.
• Quality Control Reference Material: Used by chemical suppliers and testing laboratories as a certified reference material (CRM) to calibrate instruments and verify analytical procedures.

Basic Information

Product Name	n-Nitrosodimethyl-1,1,1-D3-Amine
CAS No.	32745-07-6
Molecular Formula	C₂D₃H₃N₂O
Molecular Weight	77.10 g/mol
Synonyms	NDMA-d3; N-Nitrosodimethylamine-d3; Dimethylnitrosamine-d3; N-Methyl-N-nitroso-D3-methylamine; Deuterated N-Nitrosodimethylamine; (Dimethyl-d3)nitrosamine; N,N-Dimethylnitrosamine-d3; 1,1,1-Trideuterio-N-nitrosodimethylamine
EINECS	Contact for details

Quality Control

Our n-Nitrosodimethyl-1,1,1-D3-Amine is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for analytical reference standards. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing the chemical purity, isotopic purity (D-enrichment), and solvent content. We support compliance with pharmacopeial and ISO guidelines for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C (refrigerated) or as specified on the label or COA. Due to its highly volatile and light-sensitive nature, prolonged exposure to ambient conditions should be avoided. Keep container tightly sealed in a cool, well-ventilated place.

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 (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Solvent Content (GC)	Reported on COA

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