Description

Varenicline Impurity 3 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 tartrate, a medication used for smoking cessation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling and Identification in Varenicline Tartrate API and finished drug products.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS systems.
• Quality Control (QC) and Quality Assurance (QA) testing in GMP manufacturing environments.
• Stability Studies to monitor impurity formation in drug substances and products over time.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development of new synthetic pathways or purification processes for varenicline.
• Calibration Standard for quantitative analysis to determine impurity levels against ICH guidelines.

Basic Information

Item	Detail
Product Name	Varenicline Impurity 3
CAS No.	1333145-89-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Varenicline Related Compound 3; Varenicline EP Impurity C; Varenicline USP Impurity; 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine Impurity; CP-526555 Impurity; Champix Impurity; Chantix Impurity
EINECS	Contact for details

Quality Control

Every batch of Varenicline Impurity 3 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing identity, purity, 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 controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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