Description

5-(Methylnitrosamino)-1-(3-Pyridyl)-1-Pentanol is a nitrosamine compound of significant interest in analytical and regulatory chemistry. This compound is crucial for research and quality control, particularly in the pharmaceutical and tobacco industries, where it serves as a key biomarker and reference standard. It is primarily needed by analytical laboratories, regulatory bodies, and manufacturers requiring precise detection and quantification of nitrosamine impurities to ensure product safety and compliance with stringent global regulations.

Application

• Analytical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments like HPLC-MS/MS and GC-MS.
• Pharmaceutical Impurity Testing: Critical for the detection, identification, and quantification of nitrosamine drug substance-related impurities (NDSRIs) in active pharmaceutical ingredients (APIs) and finished drug products to comply with FDA, EMA, and ICH M7(R2) guidelines.
• Biomarker Research: Used in metabolic and exposure studies related to tobacco-specific nitrosamines (TSNAs), such as NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone).
• Tobacco and Smoke Analysis: Employed in testing smokeless tobacco, cigarette smoke, and e-cigarette vapor to assess levels of harmful and potentially harmful constituents (HPHCs).
• Method Development and Validation: Essential for developing, optimizing, and validating sensitive analytical methods for trace-level nitrosamine analysis.
• Regulatory Compliance and Quality Assurance: Supports quality control laboratories in meeting global pharmacopeial requirements (USP, EP) and regulatory submissions for nitrosamine risk assessments.
• Food Safety Testing: Applied in trace analysis for nitrosamines in certain food products and food-contact materials.
• Environmental Monitoring: Used in research to detect and measure nitrosamine contamination in water and soil samples.

Basic Information

Product Name	5-(Methylnitrosamino)-1-(3-Pyridyl)-1-Pentanol
CAS No.	887407-09-2
Molecular Formula	C11H17N3O2
Molecular Weight	223.27 g/mol
Synonyms	NNAL; 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (common misnomer, correct structure is 5-); N'-Nitrosonornicotine metabolite; 5-(N-Methyl-N-nitrosamino)-1-(3-pyridinyl)-1-pentanol; (RS)-5-(Methylnitrosamino)-1-(3-pyridyl)pentan-1-ol; Tobacco-specific nitrosamine metabolite; Hydroxy-NNK; Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Our high-purity reference standards are manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, GC-MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, impurities, and water content. We support compliance with ICH, USP, and EP guidelines for impurity standards. Custom purity grades and mixtures are available to meet specific methodological requirements.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Allow the sealed vial to equilibrate to room temperature before opening to prevent moisture condensation. Store in a cool, dry, and well-ventilated area away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
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.