Description

Methyl n-Propyl Nitrosamine CAS NO 924-46-9 is a nitrosamine compound of significant interest in chemical research and industrial process control. Its primary commercial value lies in its critical role as a reference standard and analytical marker for detecting and quantifying nitrosamine impurities in pharmaceuticals and other chemical products. This compound is essential for quality control laboratories, research institutions, and manufacturers in the pharmaceutical, agrochemical, and fine chemical sectors who require high-purity analytical standards to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Analysis: Serves as a certified reference material (CRM) for the identification and quantification of nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products, supporting compliance with stringent regulatory guidelines (e.g., FDA, EMA).
• Method Development & Validation: Used as a critical standard in developing and validating sensitive analytical methods, such as GC-MS, LC-MS/MS, and HPLC, for trace-level nitrosamine detection.
• Toxicological & Carcinogenicity Research: Employed in academic and industrial research studies to investigate the metabolic pathways, genotoxicity, and carcinogenic mechanisms of nitrosamine compounds.
• Quality Assurance & Control (QA/QC): Utilized as an internal standard or system suitability check in routine quality control laboratories to monitor manufacturing processes and ensure the absence of nitrosamine contaminants.
• Regulatory Compliance Testing: Essential for conducting required testing for nitrosamine impurities in pharmaceuticals (e.g., sartans, metformin, ranitidine) and other consumer products to meet global regulatory standards.
• Chemical Synthesis Intermediate: Acts as a specialized intermediate or model compound in organic synthesis research for studying nitrosation reactions and developing novel chemical entities.

Basic Information

Product Name	Methyl n-Propyl Nitrosamine
CAS No.	924-46-9
Molecular Formula	C₄H₁₀N₂O
Molecular Weight	102.14 g/mol
Synonyms	N-Nitroso-N-methylpropylamine; N-Methyl-N-nitroso-1-propanamine; N-Methyl-N-nitroso-propylamine; N-Nitroso-N-methyl-n-propylamine; N-Nitroso-N-methylpropylamine; N-Methyl-N-nitroso-propanamine; N-Nitroso-methylpropylamine; MNPA
EINECS	213-108-8

Quality Control

Every batch of Methyl n-Propyl Nitrosamine is manufactured and analyzed under strict quality management systems. We provide high-purity material suitable for use as an analytical reference standard, with comprehensive testing to ensure identity, purity, and traceability. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting batch-specific results including assay (by GC or HPLC), identity confirmation (by IR and/or MS), and purity profile. 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 under an inert atmosphere (e.g., nitrogen or argon) in a freezer at or below -20°C to minimize degradation and ensure long-term stability. The container should be kept in a cool, dry, and well-ventilated area dedicated for the storage of reactive and toxic chemicals. Allow the sealed container to reach room temperature before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	Clear, yellow to amber liquid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to reference mass spectrum
Assay (GC or HPLC)	≥ 98.0%
Purity (by GC-FID)	≥ 97.0%
Water Content (KF)	≤ 0.5%

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