Description

n-Nitroso Guvacoline-D4 (Major) is a deuterated isotopologue of the nitrosamine compound n-Nitroso Guvacoline, specifically designed for use as an analytical standard. This compound is critically important for ensuring accurate quantification and trace analysis in complex matrices, providing a stable internal reference to correct for instrument variability and sample preparation losses. It is primarily needed by analytical chemists and quality control laboratories in the pharmaceutical, food safety, and environmental monitoring sectors for method development, validation, and routine testing of nitrosamine impurities.

Application

• Internal Standard for LC-MS/MS: Used as a stable isotope-labeled internal standard for the precise quantification of n-Nitroso Guvacoline and related nitrosamine impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Pharmaceutical Impurity Testing: Essential for compliance with stringent regulatory guidelines (e.g., FDA, EMA) on nitrosamine risk assessment, enabling accurate detection at parts-per-billion (ppb) or lower levels.
• Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods in quality control and research laboratories.
• Food and Consumer Product Safety: Applied in testing protocols for nitrosamine contamination in foodstuffs, cosmetics, and other consumer goods where these carcinogenic compounds may form.
• Environmental Analysis: Used in trace environmental analysis to study the fate, transport, and degradation of nitrosamine compounds in water and soil.
• Metabolite and Biomarker Research: Facilitates studies on the metabolism and biological impact of nitrosamines in toxicological and pharmacological research.

Basic Information

Product Name	n-Nitroso Guvacoline-D4 (Major)
CAS No.	1330277-21-8
Molecular Formula	C7H7D4N3O2
Molecular Weight	169.19 g/mol (approx.)
Synonyms	Guvacoline-d4 Nitrosamine; 1,2,3,6-Tetrahydro-1-methyl-3,4,5,6-d4-2,3'-pyrindine-5-carboxylic acid methyl ester, N-nitroso-; Deuterated N-Nitroso Guvacoline; n-Nitroso Arecoline-d4 (Major); Nitrosoguvacoline-d4; Isotopically Labeled Nitrosamine Standard; [D4]-NGuv; Internal Standard for Nitrosamine Analysis
EINECS	Contact for details

Quality Control

Every batch of n-Nitroso Guvacoline-D4 (Major) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced spectroscopic and chromatographic techniques, to ensure compliance with the high-purity standards required for analytical reference materials. A comprehensive Certificate of Analysis (COA) detailing isotopic purity, chemical purity, and identity confirmation is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This compound is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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