Description

Varenicline Impurity 18 is a high-purity chemical reference standard used in the analytical profiling and quality control of pharmaceutical products. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) varenicline tartrate, a smoking cessation aid, by accurately identifying and quantifying process-related impurities. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing. The reliable characterization of such impurities is fundamental to meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Varenicline Impurity 18 in drug substance and drug product analysis.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC, for varenicline tartrate.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for impurity profiles required in regulatory filings (e.g., ANDA, NDA, CTA) to agencies like the US FDA and EMA.
• Research and Development: Supports process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Varenicline Impurity 18
CAS No.	2306217-11-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Varenicline Related Compound 18; Varenicline EP Impurity 18; Varenicline USP Impurity 18; 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine Impurity; Chantix Impurity 18; Champix Impurity 18; Process Impurity of Varenicline; Varenicline Tartrate Impurity 18
EINECS	Contact for details

Quality Control

Every batch of Varenicline Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. We support compliance with ICH, USP, and EP guidelines for impurity reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. For long-term stability, storage at 2°C to 8°C is recommended. The container should be kept in a well-ventilated area and handled according to laboratory safety protocols for chemical substances.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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