Description

n-Amyl-n-(3-Carboxypropyl)Nitrosamine is a specialized nitrosamine compound of significant interest in research and analytical chemistry. Its primary value lies in its use as a critical reference standard and analytical marker for nitrosamine impurity detection and quantification. This compound is essential for laboratories and manufacturers in the pharmaceutical, agrochemical, and food safety sectors who require high-purity analytical standards to ensure product safety and regulatory compliance.

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 drug products, supporting compliance with stringent regulatory guidelines (e.g., EMA, FDA).
• Analytical Method Development: Used as a key standard in developing and validating sensitive analytical methods, such as LC-MS/MS and GC-MS, for trace-level nitrosamine analysis.
• Toxicological and Carcinogenicity Research: Employed in academic and industrial research studies to investigate the metabolic pathways, genotoxicity, and carcinogenic potential of nitrosamine compounds.
• Quality Control & Assurance: Acts as a system suitability standard and for calibrating equipment in quality control laboratories to monitor and control nitrosamine levels in various chemical processes.
• Agrochemical and Chemical Safety: Used to assess and mitigate the risk of nitrosamine formation in agrochemical formulations, rubber chemicals, and other industrial products.
• Food and Consumer Product Safety: Applied in testing protocols to detect nitrosamine contaminants in foodstuffs, cosmetics, and consumer goods where nitrosating agents may be present.

Basic Information

Product Name	n-Amyl-n-(3-Carboxypropyl)Nitrosamine
CAS No.	62018-94-4
Molecular Formula	C9H18N2O3
Molecular Weight	202.25 g/mol
Synonyms	5-(N-Nitrosopentylamino)pentanoic Acid; N-Nitroso-N-pentyl-4-aminobutyric Acid; N-Amyl-N-(3-carboxypropyl)nitrosamine; N-Nitrosopentyl-4-aminobutyric Acid; APNT; N-Nitroso-N-amyl-4-aminobutyric Acid; N-Pentyl-N-(3-carboxypropyl)nitrosamine; Nitrosamylaminobutyric Acid
EINECS	Contact for details

Quality Control

Every batch of n-Amyl-n-(3-Carboxypropyl)Nitrosamine is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to ensure identity, purity, and traceability, which is critical for its use as a reference standard. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting results from advanced chromatographic and spectroscopic techniques. Our quality commitment supports compliance with relevant pharmacopeial and ICH guidelines for impurity standards.

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). Due to its light-sensitive nature, the container should be kept in secondary packaging or amber glass to prevent degradation from light exposure. Handle and store in accordance with good laboratory practices.

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%
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.