Description

n-Methyl-n-(4-Hydroxybutyl)Nitrosamine is a specialized nitrosamine compound of significant interest in chemical research and industrial process control. Its primary commercial value lies in its critical role as a reference standard and analytical marker for the detection and quantification of potentially genotoxic nitrosamine impurities in pharmaceutical products and other chemical matrices. This compound is essential for quality control laboratories in the pharmaceutical, agrochemical, and advanced materials sectors, where rigorous impurity profiling is mandated by global regulatory bodies to ensure product safety and compliance.

Application

• Pharmaceutical Impurity Analysis: Serves as a certified reference material (CRM) for the accurate quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products, supporting compliance with FDA, EMA, and ICH M7(R2) guidelines.
• Method Development and Validation: Used as a critical standard in developing and validating sensitive analytical methods, such as LC-MS/MS and GC-MS, for trace-level nitrosamine detection.
• Quality Assurance & Control: Employed in routine quality control testing to monitor and control nitrosamine levels during pharmaceutical manufacturing processes, including sartan, ranitidine, and metformin production.
• Regulatory Compliance and Audits: Provides essential data for regulatory submissions and internal audits to demonstrate control over nitrosamine genotoxic impurities (GTIs).
• Chemical Process Safety: Acts as a marker compound in chemical engineering to study and mitigate nitrosamine formation in industrial processes involving secondary or tertiary amines and nitrosating agents.

Basic Information

Product Name	n-Methyl-n-(4-Hydroxybutyl)Nitrosamine
CAS No.	51938-16-0
Molecular Formula	C5H12N2O2
Molecular Weight	132.16 g/mol
Synonyms	N-Nitroso-N-methyl-4-hydroxybutylamine; N-Methyl-N-(4-hydroxybutyl)nitrosamine; 4-Hydroxybutyl methyl nitrosamine; N-Nitroso-N-methyl-4-hydroxybutylamine; N-Methyl-N-nitroso-4-aminobutanol; MBHA; N-Nitroso-N-methyl-4-hydroxybutylamine; N-Methyl-N-(4-hydroxybutyl)nitrosoamine
EINECS	Contact for details

Quality Control

Our high-purity n-Methyl-n-(4-Hydroxybutyl)Nitrosamine is manufactured and handled under strict quality management systems. Each batch is subjected to rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for purity, related substances, and residual solvents, supporting traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). This compound is light-sensitive (store away from light) and should be handled with appropriate precautions due to its nature as a nitrosamine. Keep away from strong acids and organic solvents.

Specification

Item	Specification
Appearance	Colorless to pale yellow liquid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%

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