Tafenoquine API Manufacturer in India

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

Tafenoquine API Manufacturer in India

Tafenoquine is a long-acting 8-aminoquinoline antimalarial active pharmaceutical ingredient (API). It is associated with the treatment and prevention of malaria, particularly applications involving Plasmodium vivax and prevention of relapse. Tafenoquine has the chemical formula C24H28F3N3O3, molecular weight 463.5 g/mol, and CAS Number 106635-80-7.

Swapnroop provides Tafenoquine API for pharmaceutical development, formulation manufacturing and bulk API requirements, subject to applicable specifications and documentation.

Tafenoquine API Overview

Tafenoquine belongs to the 8-aminoquinoline class of antimalarial compounds and is structurally related to primaquine. Its long-acting profile makes it an important compound for pharmaceutical applications involving malaria prophylaxis and prevention of P. vivax relapse.

The API is chemically identified as:

4-N-[2,6-dimethoxy-4-methyl-5-[3-(trifluoromethyl)phenoxy]quinolin-8-yl]pentane-1,4-diamine.

Tafenoquine should be distinguished from its salt forms. For example, Tafenoquine Succinate has CAS Number 106635-81-8 and a different molecular formula and molecular weight.

Chemical and Pharmaceutical Profile

Tafenoquine is an aminoquinoline derivative containing a quinoline nucleus, methoxy groups, a methyl substituent, a trifluoromethyl-substituted phenoxy group and an aminoalkyl side chain.

Key chemical identifiers include:

  • Product Name: Tafenoquine
  • CAS Number: 106635-80-7
  • Molecular Formula: C24H28F3N3O3
  • Molecular Weight: 463.5 g/mol
  • PubChem CID: 115358
  • Chemical Class: 8-Aminoquinoline
  • Therapeutic Category: Antimalarial
  • InChIKey: LBHLFPGPEGDCJG-UHFFFAOYSA-N
  • IUPAC Name: 4-N-[2,6-dimethoxy-4-methyl-5-[3-(trifluoromethyl)phenoxy]quinolin-8-yl]pentane-1,4-diamine 

Pharmaceutical Applications of Tafenoquine API

Tafenoquine is used in pharmaceutical applications associated with:

  • Antimalarial drug development
  • Prevention of Plasmodium vivax malaria relapse
  • Malaria prophylaxis
  • Development of long-acting antimalarial formulations
  • Pharmaceutical research and formulation development
  • Bulk API manufacturing requirements

Its pharmacological use is associated with both blood-stage and liver-stage activity relevant to malaria, including the stages involved in P. vivax relapse.

Tafenoquine API Quality and Analytical Testing

Tafenoquine API should undergo appropriate analytical testing to establish identity, purity and compliance with the applicable product specification.

Typical analytical parameters may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Organic impurities
  • Residual solvents
  • Water content
  • Residue on ignition / sulfated ash, where applicable
  • Elemental impurities
  • Chromatographic purity
  • Physical characteristics
  • Stability-related testing

The acceptance criteria should be based on the approved Tafenoquine API specification, applicable pharmacopoeial requirements, regulatory requirements or customer-specific specifications rather than generic limits.

Tafenoquine API Manufacturer in India

Swapnroop supports pharmaceutical API requirements for domestic and international customers. Tafenoquine API can be supplied for pharmaceutical manufacturing, research and development and formulation-related applications according to agreed specifications.

Our API supply approach focuses on:

  • Consistent product quality
  • Batch-to-batch quality control
  • Analytical testing
  • Pharmaceutical-grade manufacturing support
  • Technical documentation
  • Customer-specific specifications
  • Bulk API requirements

Contact Swapnroop for current Tafenoquine API specifications, availability, packaging and technical documentation.

Packaging and Storage

Tafenoquine API should be packed in suitable pharmaceutical-grade containers that protect the material against contamination, moisture and environmental exposure.

Storage: Store in a tightly closed container under controlled conditions according to the applicable product specification, safety documentation and stability data.

Specific storage conditions should always be confirmed against the current manufacturer's specification and CoA.

Documentation

Depending on the order and applicable regulatory requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • Batch documentation
  • Analytical documentation
  • Stability information, where available
  • Technical documentation
  • Regulatory documentation, where applicable

Why Choose Tafenoquine API from Swapnroop?

Swapnroop provides pharmaceutical API solutions for formulation development, pharmaceutical manufacturing and bulk requirements. Tafenoquine API is offered as an 8-aminoquinoline antimalarial API for customers requiring a reliable pharmaceutical raw material source.

For Tafenoquine API bulk requirements, technical specifications, documentation and commercial enquiries, contact Swapnroop.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
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