Description

Varenicline Tartrate is the tartrate salt form of varenicline, a high-purity active pharmaceutical ingredient (API) with significant therapeutic importance. It functions as a partial agonist selective for the α4β2 subtype of the nicotinic acetylcholine receptor, making it a critical compound for pharmaceutical development. This material is essential for manufacturers in the global pharmaceutical industry engaged in the research, development, and production of smoking cessation therapies. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final drug product.

Application

• Primary Pharmaceutical Ingredient: The principal and most significant application is as the active pharmaceutical ingredient (API) in prescription medications for smoking cessation (e.g., Chantix®, Champix®).
• Pharmaceutical R&D: Serves as a key reference standard and starting material in preclinical and clinical research for developing new formulations and delivery systems.
• Generic Drug Manufacturing: Used by generic pharmaceutical companies to produce bioequivalent versions of branded smoking cessation drugs upon patent expiry.
• Dosage Form Development: Integral to the formulation of various solid oral dosage forms, including tablets and capsules.
• Analytical and Quality Control: Employed as a high-purity standard in analytical laboratories for method development, validation, and routine quality testing of drug products.

Basic Information

Product Name	Varenicline Tartrate
CAS No.	375815-87-5
Molecular Formula	C13H14ClN3 • C4H6O6
Molecular Weight	361.80 g/mol (for the tartrate salt)
Synonyms	7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, 2,3,4,5-tetrahydro-1,5-methano-1H-3-benzazepine, CP-526555-18, Varenicline (as tartrate), Varenicline L-tartrate, (2R,3R)-2,3-Dihydroxybutanedioic acid;7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, Chantix (API), Champix (API)
EINECS	Contact for details

Quality Control

Our Varenicline Tartrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, potency, and impurity profiles, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for tests such as assay, related substances, residual solvents, and heavy metals is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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