Description

Varenicline n-Glucoside CAS NO 873302-31-9 is a high-purity, chemically defined metabolite of varenicline, a well-known pharmaceutical agent. This compound is of significant interest for its utility as a critical reference standard and analytical marker in pharmaceutical research and development. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for drug metabolism studies, pharmacokinetic profiling, and ensuring the quality and consistency of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used for the qualitative and quantitative analysis of varenicline and its metabolites in drug substances and products.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for identifying and quantifying Phase II metabolites in in vitro and in vivo studies.
• Bioanalytical Method Development: Serves as a critical calibrant for developing and validating HPLC, LC-MS, and LC-MS/MS assays.
• Impurity Profiling: Employed to identify, monitor, and control glucuronidated impurities in varenicline API batches.
• Toxicology and Safety Assessment: Used in studies to understand the safety profile and excretion pathways of varenicline metabolites.
• Regulatory Submissions: Provides essential data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with agencies like the FDA and EMA.

Basic Information

Product Name	Varenicline n-Glucoside
CAS No.	873302-31-9
Molecular Formula	C18H22N4O7
Molecular Weight	406.39 g/mol
Synonyms	Varenicline Glucuronide; Varenicline N-Glucuronide; 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine N-glucuronide; CP-526555 Glucuronide; (2S,3S,4S,5R,6S)-6-((5,8,14-Triazatetracyclo[10.3.1.0²,¹⁰.0⁴,⁹]hexadeca-4,6,8-trien-14-yl)oxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-carboxylic acid
EINECS	Contact for details

Quality Control

Our Varenicline n-Glucoside is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, LC-MS identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to guarantee traceability and compliance.

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 kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

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 Q3C

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