Description

n-Nitrosomorpholine-D4 is a deuterated isotopologue of n-nitrosomorpholine, a stable-labeled compound used as an internal standard in analytical chemistry. This high-purity material is essential for ensuring accurate quantification and traceability in sensitive detection methods, particularly for nitrosamine analysis. It is a critical reagent for analytical laboratories and research institutions in the pharmaceutical, environmental monitoring, and food safety sectors.

Application

• Internal Standard for LC-MS/MS: Primary use as a quantitative reference standard in liquid chromatography-tandem mass spectrometry for nitrosamine impurity testing in pharmaceuticals (e.g., sartans, metformin).
• Analytical Method Development & Validation: Used to develop, calibrate, and validate highly sensitive analytical methods for trace-level detection of nitrosamines.
• Metabolic and Environmental Tracing: Employed in research studies to trace the metabolic pathways, environmental fate, and degradation products of nitrosomorpholine using deuterium as a stable isotopic label.
• Quality Control & Assurance: Serves as a critical quality control material in laboratories to ensure the accuracy and precision of nitrosamine testing protocols.
• Regulatory Compliance Testing: Supports compliance testing for regulatory bodies like the FDA and EMA regarding nitrosamine impurity limits in active pharmaceutical ingredients (APIs) and finished drug products.
• Food and Consumer Product Safety: Applied in the analysis of nitrosamines in foodstuffs, cosmetics, and rubber products where nitrosamines may be present as contaminants.

Basic Information

Product Name	n-Nitrosomorpholine-D4
CAS No.	61578-30-1
Molecular Formula	C4D4H4N2O2
Molecular Weight	120.13 g/mol (deuterated form)
Synonyms	N-Nitrosomorpholine-d4; Tetradeutero-N-nitrosomorpholine; Morpholine, N-nitroso-, d4-; N-Nitrosomorpholine (tetradeuterated); 2,3,5,6-Tetradeutero-N-nitrosomorpholine; Deuterated N-Nitrosomorpholine; Stable Labeled N-Nitrosomorpholine; NMOR-d4
EINECS	Contact for details

Quality Control

Our n-Nitrosomorpholine-D4 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity (D-enrichment), chemical purity by HPLC, and identity confirmation by spectroscopic methods. We support compliance with ICH Q3A/B, USP, and other relevant pharmaceutical guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Keep away from strong acids and organic solvents. For long-term storage, consider storage under inert atmosphere at lower temperatures (e.g., -20°C) to maximize stability.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow liquid
Identification (IR / NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by GC or HPLC)	≥ 95.0%
Water Content (KF)	≤ 0.5%

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