Description

N-Methyl-N-(3-carboxypropyl)nitrosamine is a specialized nitrosamine compound of significant interest in research and analytical chemistry. Its primary value lies in its use as a critical reference standard and analytical marker for the detection and quantification of nitrosamine impurities, which are a key focus of regulatory scrutiny in the pharmaceutical industry. This compound is essential for quality control laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, validation, and compliance testing to ensure product safety.

Application

• Pharmaceutical Impurity Testing: Serves as a high-purity analytical reference standard for the detection and quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Used in research laboratories to develop and validate sensitive analytical methods, such as LC-MS/MS and GC-MS, for trace-level nitrosamine analysis.
• Regulatory Compliance: A vital tool for conducting studies to comply with stringent regulatory guidelines from agencies like the FDA and EMA regarding nitrosamine risk assessment and control.
• Toxicological Research: Employed in academic and industrial research to study the formation, metabolism, and carcinogenic potential of nitrosamine compounds.
• Quality Assurance: Used as a system suitability check and for calibrating equipment in quality control laboratories to ensure accurate and reliable impurity profiling.

Basic Information

Product Name	N-Methyl-N-(3-carboxypropyl)nitrosamine
CAS No.	62018-90-0
Molecular Formula	C6H12N2O3
Molecular Weight	160.17 g/mol
Synonyms	N-Methyl-N-nitrosoglycine butyric acid; 4-(Methylnitrosoamino)butanoic acid; N-Methyl-N-nitroso-4-aminobutyric acid; N-Methyl-N-(3-carboxypropyl)nitrosamine; MNCPNA; N-Nitroso-N-methyl-4-aminobutyric acid; 4-[(Methylnitroso)amino]butanoic acid
EINECS	Contact for details

Quality Control

Our N-Methyl-N-(3-carboxypropyl)nitrosamine is manufactured and handled under strict quality systems to ensure the high purity and consistency required for analytical applications. Each batch is rigorously tested using advanced chromatographic and spectroscopic techniques. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided to support your research and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). For long-term stability, storage at 2-8°C is recommended. Keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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