Description

n-Nitrosobis(2-Hydroxyethyl)-D8-Amine CAS NO 1173019-53-8 is a deuterium-labeled isotopologue of a key nitrosamine compound, offering exceptional utility as a stable internal standard for analytical quantification. This high-purity labeled standard is critical for ensuring accurate and reliable detection in sensitive mass spectrometry (MS) and chromatography methods. It is primarily required by analytical laboratories, contract research organizations (CROs), and pharmaceutical quality control units for trace impurity analysis, method development, and regulatory compliance testing.

Application

• Internal Standard for LC-MS/MS: Essential for the precise quantification of nitrosamine impurities like N-nitrosodiethanolamine (NDELA) in pharmaceutical products such as Sartans, antacids, and metformin, ensuring compliance with stringent regulatory limits (e.g., EMA, FDA).
• Method Development & Validation: Used as a reference material to develop, optimize, and validate highly sensitive analytical methods for nitrosamine detection in complex matrices.
• Quality Control & Assurance: Employed in routine QC testing of active pharmaceutical ingredients (APIs), finished drug products, and raw materials to monitor and control genotoxic nitrosamine impurities.
• Environmental and Food Safety Analysis: Applied in research and testing laboratories to analyze nitrosamine levels in environmental samples, foodstuffs, and consumer products.
• Metabolic and Pharmacokinetic Studies: Serves as a tracer in advanced research studies investigating the metabolism, distribution, and fate of nitrosamine compounds.

Basic Information

Item	Details
Product Name	n-Nitrosobis(2-Hydroxyethyl)-D8-Amine
CAS No.	1173019-53-8
Molecular Formula	C₄D₈N₂O₃
Molecular Weight	164.18 g/mol (deuterated form)
Synonyms	NDELA-d8; N-Nitrosodiethanolamine-d8; Bis(2-hydroxyethyl)nitrosamine-d8; Diethanolnitrosamine-d8; N-Nitrosobis(2-hydroxyethyl)amine-d8; 2,2'-(Nitrosamino)bis(ethanol-d4); Deuteronated NDELA; Nitrosodiethanolamine Deuterated Standard
EINECS	Contact for details

Quality Control

Every batch of our n-Nitrosobis(2-Hydroxyethyl)-D8-Amine is manufactured and controlled to meet the exacting standards required for analytical reference materials. We employ rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure high chemical and isotopic purity. A comprehensive Certificate of Analysis (COA) detailing batch-specific purity, isotopic enrichment, and solvent content is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C or as indicated on the label/Certificate of Analysis. For long-term storage, keep the container in a cool, dry, and well-ventilated area. Handle and store in accordance with all applicable regulations.

Specification

Item	Specification
Appearance	Colorless to pale yellow liquid
Identification (NMR & MS)	Conforms to structure
Purity (HPLC)	≥ 98% (Chemical Purity)
Isotopic Purity (D-content)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Solvent Content (GC/HPLC)	Meets specification

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