Description

n-Nitrosobutyl-n-(4-Hydroxybutyl)Amine Glucuronide is a specific glucuronide conjugate of a nitrosamine metabolite, representing a critical reference standard in analytical and toxicological research. This compound is essential for the accurate identification and quantification of nitrosamine impurities, which are a major focus of regulatory scrutiny in the pharmaceutical and chemical industries. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and quality control departments within pharmaceutical and agrochemical manufacturers for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Testing: Serves as a certified reference material (CRM) for the detection and quantification of nitrosamine genotoxic impurities (NGIs) in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Used as a critical standard in developing and validating sensitive analytical methods, such as LC-MS/MS and HPLC, for trace-level impurity analysis.
• Toxicology and Metabolism Studies: Employed in research to study the metabolic pathways, bioactivation, and excretion profiles of nitrosamine compounds.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of analytical method specificity and accuracy for impurity control.
• Quality Control Benchmarking: Acts as a primary standard for calibrating equipment and ensuring the reliability of in-house quality control testing protocols for nitrosamine limits.
• Research on Carcinogenesis: Utilized in academic and industrial research investigating the mechanisms of nitrosamine-induced carcinogenicity.

Basic Information

Product Name	n-Nitrosobutyl-n-(4-Hydroxybutyl)Amine Glucuronide
CAS No.	79381-29-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Nitrosobutyl(4-hydroxybutyl)amine glucuronide; NBHBA-Glucuronide; N-Nitroso-N-butyl-N-(4-hydroxybutyl)amine β-D-glucopyranosiduronic acid; N-Nitrosobutyl(4-hydroxybutyl)amine β-D-glucuronide; Glucuronide conjugate of N-Nitrosobutyl(4-hydroxybutyl)amine; N-Nitrosobutyl-4-hydroxybutylamine glucuronide
EINECS	Contact for details

Quality Control

Every batch of n-Nitrosobutyl-n-(4-Hydroxybutyl)Amine Glucuronide is produced and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure they meet the exacting standards required for reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residual Solvents	Meets ICH guidelines

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