Description

n-Butyl-n-(2-Hydroxybutyl)Nitrosamine is a specialized nitrosamine compound of significant interest in chemical research and industrial process development. This chemical is primarily utilized as a critical reference standard and analytical reagent for the detection and quantification of nitrosamine impurities, which are a major focus of regulatory scrutiny in the pharmaceutical and chemical industries. It serves researchers and quality control laboratories in sectors requiring rigorous analytical method development, validation, and impurity profiling to ensure product safety and compliance.

Application

• Pharmaceutical Impurity Testing: Serves as a certified reference material (CRM) for the analysis and quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products to meet stringent FDA, EMA, and ICH guidelines.
• Analytical Method Development: Used as a standard in developing and validating sensitive analytical methods, such as LC-MS/MS and GC-MS, for trace-level nitrosamine detection.
• Chemical Research & Synthesis: Acts as a building block or intermediate in organic synthesis and research studies investigating the formation, reactivity, and toxicology of N-nitrosamines.
• Quality Assurance & Control: Employed in internal and third-party laboratory quality control programs to calibrate equipment and ensure the accuracy of nitrosamine testing protocols.
• Regulatory Compliance & Safety Assessment: Essential for conducting risk assessments, establishing permissible daily exposure (PDE) limits, and preparing regulatory submission documents for new drug applications.
• Environmental and Food Safety Analysis: Applied in research methods aimed at detecting nitrosamine contaminants in environmental samples, foodstuffs, and agricultural products.

Basic Information

Product Name	n-Butyl-n-(2-Hydroxybutyl)Nitrosamine
CAS No.	55621-29-9
Molecular Formula	C8H18N2O2
Molecular Weight	174.24 g/mol
Synonyms	N-Nitroso-N-butyl-N-(2-hydroxybutyl)amine; NBHBA; N-Butyl-N-(2-hydroxybutyl)nitrosamine; 2-Hydroxybutyl Butyl Nitrosamine; N-Butyl-N-(2-hydroxybutyl)-N-nitrosoamine; Butyl(2-hydroxybutyl)nitrosamine; N-Nitrosobutyl(2-hydroxybutyl)amine
EINECS	Contact for details

Quality Control

Our n-Butyl-n-(2-Hydroxybutyl)Nitrosamine is produced and handled under strict quality management protocols. Each batch is subjected to comprehensive analytical testing, including HPLC, GC-MS, and NMR for identity confirmation and purity assessment, ensuring it meets the exacting standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data. We support compliance with ICH Q3, USP general chapters, and relevant pharmacopeial guidelines for impurity standards.

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). Due to its light-sensitive and easily oxidized nature, it is recommended to store the product under an inert atmosphere (e.g., nitrogen or argon) for long-term stability. Keep away from heat, sparks, and open flame.

Specification

Item	Specification
Appearance	Colorless to pale yellow liquid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C limits

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