Description

1-Nitrosopyrrolidine-D4 is a deuterium-labeled isotopologue of the nitrosamine 1-nitrosopyrrolidine, a compound of significant interest in analytical and research chemistry. Its primary value lies in its use as a high-purity internal standard for precise quantification and method validation in mass spectrometry. This stable isotope-labeled compound is essential for researchers and quality control laboratories in the pharmaceutical, food safety, and environmental monitoring sectors, where accurate detection of trace nitrosamine impurities is critical for regulatory compliance and product safety.

Application

• Internal Standard for LC-MS/MS: Used as a deuterated surrogate for the accurate quantification of 1-nitrosopyrrolidine and related nitrosamines in complex matrices.
• Pharmaceutical Impurity Testing: Critical for method development and validation in the analysis of nitrosamine drug substance-related impurities (NDSRIs) to meet stringent regulatory guidelines (e.g., FDA, EMA).
• Food and Beverage Safety Analysis: Employed in the detection and measurement of nitrosamines in processed foods, cured meats, and alcoholic beverages.
• Environmental and Water Monitoring: Aids in the trace analysis of nitrosamine contaminants in water supplies and industrial effluents.
• Metabolic and Toxicological Studies: Serves as a stable isotope tracer in research investigating the metabolism, distribution, and toxicity of nitrosamines.
• Reference Material for Calibration: Provides a certified reference material for calibrating analytical instruments and ensuring data integrity in testing laboratories.

Basic Information

Product Name	1-Nitrosopyrrolidine-D4
CAS No.	57371-40-1
Molecular Formula	C₄D₈N₂O
Molecular Weight	116.17 g/mol
Synonyms	N-Nitrosopyrrolidine-d8; Pyrrolidine, 1-nitroso-, tetradeutero; Deuterated N-Nitrosopyrrolidine; N-Nitrosopyrrolidine (tetradeutero); NPYR-d4; 1-NP-d4; Tetradeutero-1-nitrosopyrrolidine; [2H4]-1-Nitrosopyrrolidine
EINECS	Contact for details

Quality Control

Our 1-Nitrosopyrrolidine-D4 is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for analytical standards. Each batch is characterized using advanced techniques including NMR, HPLC, and mass spectrometry to confirm identity, purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results. Our quality commitment supports compliance with GMP principles for laboratory reagents and aligns with the needs of pharmacopeial and ISO 17025-accredited testing environments.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C (refrigerated) or as specified on the label or Certificate of Analysis. For long-term storage under inert atmosphere, consult the material safety data sheet.

Specification

Item	Specification
Appearance	Yellow to orange liquid or low-melting solid
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0% (chemical purity)
Isotopic Purity (MS)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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