Description

n-Nitrosomethyloctylamine is a specific nitrosamine compound of significant interest in research and analytical chemistry. This chemical is primarily utilized as a critical reference standard and analytical reagent for the detection and quantification of nitrosamine impurities, which are a key focus of regulatory scrutiny in the pharmaceutical industry. It serves as an essential tool for quality control laboratories, research institutions, and manufacturers requiring precise analytical methods to ensure product safety and compliance with stringent global regulations.

Application

• Pharmaceutical Impurity Analysis: Serves as a certified reference material (CRM) for method development and validation in the detection of nitrosamine genotoxic impurities (GTIs) in active pharmaceutical ingredients (APIs) and drug products.
• Analytical Standard: Used for calibrating equipment such as GC-MS, LC-MS/MS, and HPLC systems to ensure accurate and reliable quantification of nitrosamine levels.
• Regulatory Compliance Testing: Essential for conducting tests to meet requirements from agencies like the FDA, EMA, and other global health authorities regarding nitrosamine risk assessment.
• Research & Development: Employed in toxicological studies and chemical research to understand the formation, stability, and properties of nitrosamine compounds.
• Quality Assurance/Quality Control (QA/QC): Used in internal laboratory quality control protocols to monitor analytical performance and ensure data integrity.

Basic Information

Product Name	n-Nitrosomethyloctylamine
CAS No.	34423-54-6
Molecular Formula	C₉H₂₀N₂O
Molecular Weight	172.27 g/mol
Synonyms	N-Methyl-N-nitrosooctylamine; N-Nitroso-N-methyloctylamine; Methyloctylnitrosamine; 1-Octyl-1-methyl-2-oxohydrazine; N-Methyl-N-nitroso-1-octanamine; N-Nitroso(methyl)(octyl)amine
EINECS	Contact for details

Quality Control

Our n-Nitrosomethyloctylamine is produced and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods and purity assessment by chromatographic techniques, to ensure it meets the high standards required for reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data, including purity, is provided with every shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) under an inert atmosphere to minimize the risk of oxidation. Keep away from heat and incompatible materials.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow liquid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
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.