Description

n-Nitroso-N,n-Di(3,5,5-Trimethylhexyl)Amine-D4 is a deuterated isotopologue of a nitrosamine compound, specifically designed for use as an analytical standard and reference material. This high-purity compound is critical for ensuring accurate quantification and method validation in sensitive analytical techniques. It is primarily utilized by research institutions, analytical laboratories, and quality control departments in the pharmaceutical and chemical industries where precise detection of nitrosamine impurities is paramount.

Application

• Primary use as an internal standard or reference standard in Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) for nitrosamine analysis.
• Method development and validation for the trace-level detection of nitrosamine impurities in Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Calibration standard in quantitative analytical workflows to ensure regulatory compliance with strict limits on nitrosamine content (e.g., as per ICH M7, FDA, EMA guidelines).
• Research applications in studying the environmental fate, metabolism, or toxicokinetics of nitrosamine compounds using deuterium-labeled analogs.
• Quality control applications in chemical manufacturing to monitor for potential nitrosamine formation during synthesis or storage processes.

Basic Information

Product Name	n-Nitroso-N,n-Di(3,5,5-Trimethylhexyl)Amine-D4
CAS No.	1346603-10-8
Molecular Formula	C24H44D4N2O
Molecular Weight	~ 380.66 g/mol
Synonyms	NDiTMA-D4; N-Nitrosodi(3,5,5-trimethylhexyl)amine-d4; Deuterated N-Nitrosodiisobutylamine (analog); N-Nitroso-N,N-bis(3,5,5-trimethylhexyl)amine-d4; N-Nitrosodihydroabiethylamine-d4 (related); Isotopically Labeled Nitrosamine Standard; Nitrosamine-d4 Internal Standard; 3,5,5-Trimethylhexyl Nitrosamine-d4 Derivative
EINECS	Contact for details

Quality Control

Our n-Nitroso-N,n-Di(3,5,5-Trimethylhexyl)Amine-D4 is manufactured and handled under strict quality systems to ensure the integrity required for analytical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing isotopic purity, chemical purity, and confirming identity. We ensure compliance with relevant standards for high-purity analytical reagents.

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). Keep away from strong bases and incompatible materials such as strong oxidizing agents. For long-term storage, consider storing under an inert atmosphere to maximize stability.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow liquid
Identification (IR / NMR)	Conforms to structure
Assay (HPLC / GC)	≥ 98.0% (Chemical Purity)
Isotopic Purity (D-content)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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