Description

n-Nitrosopyrrolidine-D8 is a stable isotope-labeled analog of n-nitrosopyrrolidine, a potent nitrosamine impurity of significant regulatory concern. This deuterated compound is an essential internal standard for accurate quantification in sensitive analytical methods, ensuring data integrity and regulatory compliance. It is primarily used by analytical laboratories and pharmaceutical manufacturers engaged in trace-level analysis and method development for nitrosamine risk assessment.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of n-nitrosopyrrolidine in pharmaceutical products, food, and environmental samples.
• Method Development & Validation: Used to develop, optimize, and validate highly sensitive analytical methods for nitrosamine detection.
• Regulatory Compliance Testing: Supports testing mandated by global health authorities (e.g., FDA, EMA) for nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Food Safety Analysis: Employed in the analysis of nitrosamines in processed foods, particularly cured meats and certain beverages.
• Environmental Monitoring: Aids in the detection and study of nitrosamine contamination in water and soil.
• Metabolic and Pharmacokinetic Studies: Serves as a tracer in research investigating the metabolism and fate of nitrosamines.
• Quality Control Reference Material: Acts as a certified reference material for laboratory quality assurance and proficiency testing.

Basic Information

Product Name	n-Nitrosopyrrolidine-D8
CAS No.	1219802-09-1
Molecular Formula	C4D8N2O
Molecular Weight	116.18 g/mol
Synonyms	N-Nitrosopyrrolidine-d8; Pyrrolidine, 1-nitroso-, d8; N-NP-d8; Deuterated N-Nitrosopyrrolidine; N-Nitrosopyrrolidine (pyrrolidine-d8); 1-Nitrosopyrrolidine-d8; [2H8]-N-Nitrosopyrrolidine; Stable Isotope Labeled N-Nitrosopyrrolidine
EINECS	Contact for details

Quality Control

Our n-Nitrosopyrrolidine-D8 is produced and handled under strict quality systems to ensure the high isotopic purity and chemical stability required for analytical standards. Each batch is characterized by advanced spectroscopic and chromatographic techniques. A comprehensive Certificate of Analysis (COA) is provided, detailing isotopic enrichment (D-atom %), chemical purity, and identity confirmation, supporting its use in GLP/GMP compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere (e.g., argon or nitrogen) to minimize oxidation and degradation. Allow the sealed vial to equilibrate to room temperature before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow solution or solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Isotopic Purity (D-atom %)	≥ 98%
Chemical Purity (HPLC)	≥ 98%
Concentration (if in solution)	1.0 mg/mL ± 5% in specified solvent
Solvent (if applicable)	Methanol, Acetonitrile, or other specified

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