Description

Varenicline Impurity 15 is a high-purity reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on the development and manufacturing of varenicline-based therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Identification and Profiling: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify this specific impurity in varenicline API and finished drug products.
• Quality Control and Release Testing: Integral part of the in-house QC testing protocol to ensure API batches meet stringent impurity limits as per ICH guidelines.
• Regulatory Submission and Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed as a marker to monitor impurity levels in stability samples under various ICH storage conditions.
• Process Chemistry Optimization: Used by chemical development scientists to monitor and minimize the formation of this impurity during API synthesis and purification steps.

Basic Information

Product Name	Varenicline Impurity 15
CAS No.	2306217-12-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Varenicline Related Compound 15; Varenicline EP Impurity I; Varenicline USP Impurity; 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine Impurity; Chantix Impurity 15; CP-526555 Impurity 15; (2R,3R)-2,3,4,5-Tetrahydro-1H-3-benzazepine-2,3-diol Impurity
EINECS	Contact for details

Quality Control

Every batch of Varenicline Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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