Description

Varenicline Carbamoyl β-D-Glucuronide is a key metabolite and reference standard of the smoking cessation drug varenicline. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in the development and quality control of varenicline-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of varenicline and its metabolites in various matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance rates, and bioavailability of varenicline in preclinical and clinical research.
• Bioanalytical Method Development: Critical for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring and pharmacokinetic profiling.
• Impurity Profiling and Characterization: Employed to identify, quantify, and qualify process-related impurities and degradation products in varenicline active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Compliance and Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive data on drug metabolism for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Clinical Research: Used as a calibrator or control in studies assessing patient adherence, dose proportionality, and drug-drug interactions involving varenicline.

Basic Information

Product Name	Varenicline Carbamoyl β-D-Glucuronide
CAS No.	535920-98-0
Molecular Formula	C15H20N4O8
Molecular Weight	384.34 g/mol
Synonyms	Varenicline N-Carbamoyl-β-D-Glucuronide; 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine-2-carboxamide, 6-(β-D-glucopyranuronosyloxy)-; Varenicline Carbamoyl Glucuronide; Varenicline Metabolite; CP-533,633; (2S,3S,4S,5R,6S)-6-((5,8,14-Triazatetracyclo[10.3.1.0²,⁶.0⁷,¹¹]hexadeca-1(16),7,9,11,13-pentaen-14-yl)oxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-carboxylic acid
EINECS	Contact for details

Quality Control

Our Varenicline Carbamoyl β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥95.0%
Water Content (KF)	≤5.0%
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.