Description

2-Oxopropyl-n-Propylnitrosamine is a specialized nitrosamine compound of significant interest in research and analytical chemistry. This chemical is primarily utilized as a critical reference standard and analytical reagent for method development and quality control testing. It is essential for laboratories and industries requiring precise detection and quantification of nitrosamine impurities, particularly in pharmaceutical and chemical manufacturing. Our supply ensures high purity and batch-to-batch consistency to meet rigorous analytical demands.

Application

• Primary use as a certified reference material (CRM) for calibrating analytical instrumentation.
• Critical analytical standard for developing and validating methods to detect nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Used in quality control (QC) and quality assurance (QA) laboratories to ensure compliance with stringent regulatory limits for genotoxic impurities.
• Employed in research and development (R&D) studies investigating the formation, fate, and mitigation of nitrosamines in chemical processes.
• Serves as a key reagent in methodology transfer and inter-laboratory comparison studies.
• Applied in environmental testing and toxicological research concerning nitrosamine exposure and analysis.

Basic Information

Product Name	2-Oxopropyl-n-Propylnitrosamine
CAS No.	39603-54-8
Molecular Formula	C6H12N2O2
Molecular Weight	144.17 g/mol
Synonyms	N-Nitroso-N-propylacetamide; N-Propyl-N-nitrosoacetamide; N-Nitroso-N-propylacetamide; Acetamide, N-nitroso-N-propyl-; N-Nitroso-N-propylacetamide; NPA; N-Nitroso-N-propylacetamide; 1-Oxo-1-(propylnitrosamino)propane
EINECS	Contact for details

Quality Control

Every batch of 2-Oxopropyl-n-Propylnitrosamine is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity confirmation, and analytical results. We support compliance with ICH Q3 guidelines and other relevant regulatory frameworks for genotoxic impurities.

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). Due to its light-sensitive nature, containers should be kept in opaque packaging or amber glass. Keep away from heat, sparks, and open flame.

Specification

Item	Specification
Appearance	Yellow to orange liquid or solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Report and identify any significant impurities

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