Description

Varenicline Impurity 17 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Varenicline, a smoking cessation aid. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and quality control of Varenicline API.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate detection and quantification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies of Varenicline to understand impurity formation pathways and establish shelf-life.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Used as an in-house reference standard in QC laboratories for routine batch release testing of Varenicline drug substances and products.
• Research & Development: Supports R&D activities aimed at process optimization, impurity synthesis, and understanding the chemical behavior of Varenicline.

Basic Information

Product Name	Varenicline Impurity 17
CAS No.	853946-18-6
Molecular Formula	C13H13N3
Molecular Weight	211.26 g/mol
Synonyms	7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine; Varenicline Related Compound; Varenicline Process Impurity; Varenicline Degradant; CP-526555 Impurity; Champix Impurity; Chantix Impurity
EINECS	Contact for details

Quality Control

Every batch of Varenicline Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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