Description

4-Methylnitrosopiperidine is a specialized nitrosamine compound of significant interest in advanced chemical research and development. Its primary value lies in its utility as a critical reference standard and analytical reagent for the detection and quantification of nitrosamine impurities, a key focus area in pharmaceutical quality control. This product is essential for laboratories and manufacturers in the pharmaceutical, analytical chemistry, and toxicology sectors who require high-purity materials for method development, validation, and compliance testing.

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 drug products, supporting compliance with regulatory guidelines (e.g., FDA, EMA).
• Method Development & Validation: Used as a standard in developing and validating sensitive analytical methods such as LC-MS/MS, GC-MS, and HPLC for trace-level nitrosamine detection.
• Toxicological Research: Employed in academic and industrial research studies to investigate the metabolism, genotoxicity, and carcinogenic mechanisms of nitrosamine compounds.
• Quality Control Laboratories: Acts as a system suitability standard and for calibrating equipment in quality control labs to ensure accurate and reliable impurity profiling.
• Regulatory Compliance Testing: Critical for conducting forced degradation studies and stability testing to assess the potential formation of nitrosamines in pharmaceutical formulations.

Basic Information

Product Name	4-Methylnitrosopiperidine
CAS No.	15104-03-7
Molecular Formula	C6H12N2O
Molecular Weight	128.17 g/mol
Synonyms	N-Nitroso-4-methylpiperidine; 4-Methyl-N-nitrosopiperidine; 1-Nitroso-4-methylpiperidine; 4-Methylpiperidine, N-nitroso-; N-Methyl-N-nitrosopiperidine (common misnomer, clarify structure); MNIP; NSC 93745
EINECS	Contact for details

Quality Control

Every batch of our 4-Methylnitrosopiperidine is produced and handled under strict quality management protocols. We provide comprehensive analytical data to support its use as a high-grade reference material. Certificates of Analysis (COA) are supplied with each shipment, detailing purity, identity confirmation, and impurity profiles as determined by techniques including HPLC, GC-MS, and NMR. Our quality system is designed to meet the exacting standards required for analytical and research applications.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen or argon) at controlled room temperature (15-25°C) or as specified on the label or COA. Due to its light-sensitive and easily oxidized nature, prolonged exposure to light, air, or elevated temperatures should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to orange liquid or low-melting solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Contact for details
Water Content (KF)	< 0.5%

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