Description

Varenicline Impurity 13 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, varenicline tartrate. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and impurity profiling studies. This impurity standard supports the stringent quality control processes mandated in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in varenicline tartrate drug substance and finished products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing of batches to monitor and control impurity levels, ensuring drug product safety and efficacy.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of varenicline formulations.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for varenicline.

Basic Information

Product Name	Varenicline Impurity 13
CAS No.	357424-07-8
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 13; Varenicline EP Impurity G; Varenicline USP Impurity; CP-526555 Impurity; (1R,4S)-4-(2-Azabicyclo[2.2.1]hept-5-yl)-1H-indazole
EINECS	Contact for details

Quality Control

Our Varenicline Impurity 13 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, NMR), assay (by HPLC), and related substance analysis. We support compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). The material is hygroscopic and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

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

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