Description

2-Hydroxypropyl-n-Propylnitrosamine is a specialized nitrosamine compound of significant interest in chemical research and development. This substance is primarily utilized as a critical reference standard and analytical reagent for the detection and quantification of nitrosamine impurities, which are a major focus in pharmaceutical quality control. Industries requiring rigorous impurity profiling, such as pharmaceutical manufacturing, contract research organizations (CROs), and analytical testing laboratories, rely on high-purity nitrosamine standards to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Testing: Serves as a certified reference material (CRM) for the accurate quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used as a standard to develop and validate sensitive analytical methods, such as LC-MS/MS and GC-MS, for trace-level nitrosamine analysis.
• Regulatory Compliance & Safety Assessment: Essential for conducting risk assessments and ensuring compliance with stringent global regulations (e.g., FDA, EMA, ICH M7) regarding mutagenic impurities.
• Chemical Research: Employed in academic and industrial research studies investigating the formation, chemistry, and toxicology of N-nitrosamines.
• Quality Control Laboratories: Used for system suitability testing, calibration, and ongoing quality assurance in labs monitoring nitrosamine levels.

Basic Information

Product Name	2-Hydroxypropyl-n-Propylnitrosamine
CAS No.	39603-53-7
Molecular Formula	C6H14N2O2
Molecular Weight	146.19 g/mol
Synonyms	N-Nitroso-N-propyl-2-hydroxypropylamine; 1-(N-Nitroso-N-propylamino)-2-propanol; N-Propyl-N-(2-hydroxypropyl)nitrosamine; HPAN; 2-Hydroxypropyl propyl nitrosamine; N-Nitroso(2-hydroxypropyl)propylamine; N-Nitroso-N-propyl-2-hydroxypropylamine
EINECS	Contact for details

Quality Control

Our 2-Hydroxypropyl-n-Propylnitrosamine is manufactured and handled under strict quality systems to ensure the highest standards of purity and consistency, which are non-negotiable for its use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation, and impurity profiles via validated analytical methods. We support compliance with ICH Q3A, Q3B, and M7 guidelines, and our quality commitment aligns with the needs of GMP/GLP environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its nature, keep away from strong acids and incompatible organic solvents. For long-term stability, consider storage under inert atmosphere.

Specification

Item	Specification
Appearance	Colorless to pale yellow liquid
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Purity (GC)	≥ 97.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH limits

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