Description

Varenicline Impurity 6 is a high-purity chemical 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, Varenicline, a medication used for smoking cessation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Varenicline API and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, for impurity separation and analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing of pharmaceutical batches.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Varenicline formulations.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Varenicline.

Basic Information

Item	Detail
Product Name	Varenicline Impurity 6
CAS No.	1026685-55-1
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; Chantix Impurity; CP-526555 Impurity; (1R,2R,4S,5S,6R)-2,6-Diazatricyclo[3.3.1.13,7]decane derivative
EINECS	Contact for details

Quality Control

Every batch of Varenicline Impurity 6 (CAS 1026685-55-1) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, GC, NMR, and MS. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider storing under an inert atmosphere.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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