Description

Di-sec-Butylnitrosamine is a specific nitrosamine compound of significant interest in analytical chemistry and industrial research. Its primary value lies in its use 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. This compound is essential for quality control laboratories, research institutions, and manufacturers requiring high-purity analytical standards to ensure product safety and compliance with stringent global regulations.

Application

• Pharmaceutical Impurity Testing: Serves as a certified reference material (CRM) for the identification and quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products, supporting compliance with FDA, EMA, and ICH guidelines.
• Analytical Method Development & Validation: Used as a key standard in developing and validating sensitive analytical methods, such as GC-MS, LC-MS/MS, and HPLC, for trace-level nitrosamine analysis.
• Chemical Research & Synthesis: Employed as a reagent or intermediate in organic synthesis and chemical research to study nitrosation reactions and the properties of N-nitroso compounds.
• Quality Assurance & Control: Critical for internal quality control programs within chemical manufacturing to monitor for potential nitrosamine formation during production processes.
• Regulatory Compliance & Safety Assessment: Used in toxicological studies and risk assessments to understand the potency and behavior of specific nitrosamines, aiding in the establishment of permissible daily intake (PDI) limits.
• Environmental Analysis: Applied as a standard in testing for nitrosamine contaminants in environmental samples, such as water and soil.

Basic Information

Product Name	Di-sec-Butylnitrosamine
CAS No.	5350-17-4
Molecular Formula	C8H18N2O
Molecular Weight	158.24 g/mol
Synonyms	N,N-Di-sec-butylnitrosamine; N-Nitrosodi-sec-butylamine; Di-s-butylnitrosamine; N,N-Bis(1-methylpropyl)nitrous amide; N-Nitroso-N,N-di-sec-butylamine; N-Nitrosodi(sec-butyl)amine; DSBN; NDBA (commonly used for N-Nitrosodibutylamine, verify isomer specificity)
EINECS	226-302-5

Quality Control

Our Di-sec-Butylnitrosamine is produced and handled under strict quality management protocols. Each batch is subjected to rigorous analytical testing, including chromatographic purity assays and identity confirmation, to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing purity, assay results, and analytical methods (e.g., HPLC, GC-MS) is provided with every shipment to support your quality and regulatory documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at controlled room temperature (typically 15-25°C). Keep away from heat, sparks, and open flame. Due to its light-sensitive nature, containers should be amber-colored or stored in opaque secondary packaging.

Specification

Item	Specification
Appearance	Clear, yellow to amber liquid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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