Varenicline Tartrate API Manufacturer and Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Varenicline Tartrate API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Varenicline Tartrate API for pharmaceutical formulation, development and regulated pharmaceutical manufacturing applications.

Varenicline Tartrate is the tartrate salt of varenicline, a synthetic small-molecule pharmaceutical ingredient and a partial agonist of nicotinic acetylcholine receptors, particularly the α4β2 nicotinic receptor subtype. It is used in pharmaceutical products intended to support smoking cessation.

Varenicline Tartrate is identified by CAS No. 375815-87-5, with molecular formula C17H19N3O6 and molecular weight approximately 361.35–361.65 g/mol, depending on the reported molecular-weight convention and database source.

Varenicline Tartrate API Overview

Varenicline Tartrate is a crystalline pharmaceutical salt formed from one equivalent of varenicline and one equivalent of L-(+)-tartaric acid. The active moiety, varenicline, has molecular formula C13H13N3 and molecular weight 211.26 g/mol.

Regulatory documentation for varenicline tartrate identifies active-substance controls including appearance, IR and HPLC identification, assay, tartaric acid content, water, residue on ignition, impurities and residual solvents.

Chemical and Pharmaceutical Profile

  • Product Name: Varenicline Tartrate
  • CAS Number: 375815-87-5
  • Molecular Formula: C17H19N3O6
  • Molecular Weight: 361.35 g/mol
  • UNII: 82269ASB48
  • Active Moiety: Varenicline
  • Therapeutic Category: Smoking Cessation / CNS
  • Pharmacological Class: Nicotinic Acetylcholine Receptor Partial Agonist
  • API Type: Synthetic Small-Molecule API
  • Physical Form: Crystalline powder
  • Appearance: White to off-white to slightly yellow powder
  • Salt Form: Tartrate

Pharmaceutical Applications

Varenicline Tartrate API is used in pharmaceutical development and manufacturing of products for:

  • Smoking cessation
  • Tobacco-dependence treatment
  • Nicotinic receptor pharmacology
  • CNS pharmaceutical research
  • Oral pharmaceutical formulation development

Varenicline Tartrate API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals provides Varenicline Tartrate API manufacturing and supply support for pharmaceutical customers requiring controlled-quality active pharmaceutical ingredients.

As a Varenicline Tartrate API manufacturer and supplier in India, Swapnroop focuses on consistent API quality, controlled specifications, analytical documentation and reliable pharmaceutical supply.

Packaging and Storage

Varenicline Tartrate should be stored in suitable, tightly closed pharmaceutical-grade containers under controlled conditions. Protection from excessive moisture and environmental exposure should be maintained according to the applicable material specification.

Documentation

Typical pharmaceutical documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Batch Analytical Report
  • Safety Data Sheet (SDS)
  • Manufacturing Documentation
  • Regulatory Documentation, where applicable
  • Stability Documentation, where applicable

Why Choose Swapnroop for Varenicline Tartrate API?

Swapnroop Drugs & Pharmaceuticals supports pharmaceutical manufacturers and customers seeking reliable Varenicline Tartrate API with controlled quality, appropriate analytical documentation and professional technical support.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0%–102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
pH (1% Solution) 3.78 — 1%
Melting Point 195.8–197.5°C
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