Description

Varenicline Impurity 8 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient, Varenicline Tartrate. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential tool for professionals engaged in method development, stability studies, and batch release testing within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Varenicline Tartrate (Chantix®/Champix®) drug substance and drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity separation and detection.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity over time.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive identification and characterization data for specified impurities.
• Pharmacopoeial Testing: Used to ensure compliance with pharmacopoeial monographs (USP, EP, BP) that specify limits for known and unknown impurities.
• Research & Development: Serves as a critical material in R&D for studying the synthesis pathway, degradation profile, and purification processes of Varenicline.

Basic Information

Product Name	Varenicline Impurity 8
CAS No.	950781-91-6
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 8; Varenicline EP Impurity G; Varenicline USP Impurity; Chantix Impurity 8; Champix Impurity 8; (1R,4S)-4-(2-Azabicyclo[2.2.1]heptan-5-yl)-1H-1,2,3-triazole
EINECS	Contact for details

Quality Control

Every batch of Varenicline Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to maximize stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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