Description

Varenicline Impurity 13 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the smoking cessation drug varenicline tartrate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in varenicline tartrate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurities during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) over time.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and to improve purification processes for the main API.

Basic Information

Product Name	Varenicline Impurity 13 Hcl
CAS No.	1350219-74-7
Molecular Formula	C13H14ClN3
Molecular Weight	247.72 g/mol
Synonyms	Varenicline Related Compound 13 Hydrochloride; 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine Hydrochloride Impurity; Varenicline EP Impurity H HCl; Varenicline USP Impurity 13; (1R,4S)-4-[(2-Amino-5-chloropyridin-3-yl)methyl]-2,5-diazabicyclo[4.2.0]octan-3-one Hydrochloride; Varenicline Degradant 13 HCl; Chantix Impurity 13 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Varenicline Impurity 13 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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