Description

tert-Butylmethylnitrosamine is a specialized nitrosamine compound with the CAS registry number 2504-18-9. This chemical is of significant importance in research and development, particularly in analytical chemistry and toxicology studies. It serves as a critical reference standard and intermediate for scientists and quality control laboratories requiring precise materials for method development and validation.

Application

• Analytical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods, especially for nitrosamine impurity analysis.
• Pharmaceutical Research: Employed in toxicological studies and risk assessment of nitrosamine impurities (e.g., N-Nitrosodimethylamine, NDMA) in active pharmaceutical ingredients (APIs) and drug products to ensure patient safety.
• Method Development: Critical for developing and optimizing sensitive analytical techniques such as GC-MS, LC-MS/MS, and HPLC for the detection and quantification of trace-level genotoxic impurities.
• Quality Control & Assurance: Used by QC laboratories in the pharmaceutical and chemical industries to establish system suitability and ensure the accuracy and precision of impurity profiling.
• Academic & Industrial Research: Serves as a building block or model compound in chemical synthesis and research studies focusing on the properties, formation, and mitigation of nitrosamines.
• Regulatory Compliance Testing: Essential for conducting tests required to meet stringent global regulatory guidelines (e.g., FDA, EMA, ICH M7) regarding mutagenic impurities in pharmaceuticals.

Basic Information

Product Name	tert-Butylmethylnitrosamine
CAS No.	2504-18-9
Molecular Formula	C5H12N2O
Molecular Weight	116.16 g/mol
Synonyms	N-Methyl-N-(tert-butyl)nitrous amide; N-tert-Butyl-N-methylnitrosamine; N-Methyl-N-nitroso-tert-butylamine; N-Nitroso-N-methyl-tert-butylamine; t-Butylmethylnitrosamine; MTBN; N-Methyl-N-(1,1-dimethylethyl)nitrous amide; N-Nitroso(tert-butyl)methylamine
EINECS	Contact for details

Quality Control

Our tert-Butylmethylnitrosamine is produced and handled under strict quality management protocols. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the exacting standards required for research and reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, well-ventilated place at controlled room temperature (15-25°C). Due to its highly volatile nature, ensure containers are securely sealed and stored upright. Keep away from heat, sparks, and open flame.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow liquid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 2.0%

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