Description

n-Nitroso-n-(Methyl-D3)-4-Aminobutyric Acid CAS NO 1184996-41-5 is a deuterated isotopologue of a nitrosamine derivative, featuring a selectively labeled methyl group. This compound is of significant value as a high-purity analytical standard and a stable isotope-labeled internal standard for mass spectrometry. It is primarily required by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in trace analysis, method development, and regulatory compliance testing for nitrosamine impurities.

Application

• Internal Standard for LC-MS/MS: Used as a deuterium-labeled internal standard for the accurate quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products, ensuring method robustness and regulatory compliance.
• Metabolic Tracing Studies: Employed in pharmaceutical and biochemical research to trace metabolic pathways and study the biotransformation of nitrosamine compounds using stable isotope labeling techniques.
• Analytical Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating highly sensitive analytical methods (e.g., HPLC, GC-MS) for nitrosamine detection.
• Quality Control & Assurance: Essential for in-house quality control laboratories to establish and maintain stringent impurity profiling protocols for pharmaceutical raw materials and intermediates.
• Regulatory Compliance & Safety Testing: Supports compliance with stringent global regulatory guidelines (e.g., FDA, EMA, ICH) mandating the control and monitoring of nitrosamine genotoxic impurities (GTIs) in pharmaceuticals.
• Research on Nitrosamine Formation & Inhibition: Utilized as a model compound in research studies investigating the mechanisms of nitrosamine formation and the efficacy of inhibiting agents.

Basic Information

Product Name	n-Nitroso-n-(Methyl-D3)-4-Aminobutyric Acid
CAS No.	1184996-41-5
Molecular Formula	C5H6D3N2O3
Molecular Weight	148.15 g/mol
Synonyms	4-Amino-N-(methyl-d3)-N-nitrosobutanoic acid; N-Nitroso-N-(methyl-d3)-4-aminobutyric Acid; (Methyl-d3)nitrosamino-γ-aminobutyric Acid; Deuteronitrosoaminobutyric Acid (labeled); N-Methyl-d3-N-nitroso-4-aminobutyric Acid; N-Nitroso-N-(trideuteriomethyl)-4-aminobutanoic Acid; Stable Isotope Labeled Nitrosamine Standard; d3-NMABA
EINECS	Contact for details

Quality Control

Every batch of n-Nitroso-n-(Methyl-D3)-4-Aminobutyric Acid is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a certified reference material. Our products undergo rigorous quality testing, including isotopic purity and chemical purity assays, to ensure compliance with industry standards for high-purity analytical reagents. Certificates of Analysis (COA) detailing batch-specific results for identity, purity (HPLC), isotopic enrichment (NMR/MS), and related substances are available upon request.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at 2-8°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Allow the container to reach ambient temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (d3)	≥ 98 atom % D
Related Substances (HPLC)	≤ 2.0% total
Water Content (KF)	≤ 0.5%

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