Oxantel API Manufacturer in India

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Oxantel API is a synthetic anthelmintic compound belonging to the tetrahydropyrimidine/styrenic anthelmintic class. It is structurally related to pyrantel and is primarily recognized for activity against gastrointestinal nematode parasites. PubChem identifies Oxantel under CAS No. 36531-26-7, with molecular formula C13H16N2O and molecular weight 216.28 g/mol. The preferred chemical name is 3-[(E)-2-(1-methyl-5,6-dihydro-4H-pyrimidin-2-yl)ethenyl]phenol.

Oxantel is most commonly encountered in pharmaceutical products as Oxantel Pamoate, also called Oxantel Embonate. FDA's Substance Registration System identifies Oxantel Pamoate as a 1:1 salt of oxantel and pamoic acid, with CAS No. 68813-55-8, molecular formula C36H32N2O7, and molecular weight 604.6 g/mol.

Oxantel API Overview

  • Product Name: Oxantel
  • Alternative Name: Oxantelum
  • Pharmaceutical Salt: Oxantel Pamoate
  • Oxantel CAS Number: 36531-26-7
  • Oxantel Pamoate CAS Number: 68813-55-8
  • Oxantel Molecular Formula: C13H16N2O
  • Oxantel Molecular Weight: 216.28 g/mol
  • Oxantel Pamoate Molecular Formula: C36H32N2O7
  • Oxantel Pamoate Molecular Weight: 604.6 g/mol
  • PubChem CID – Oxantel: 5281087
  • PubChem CID – Oxantel Pamoate: 5281086
  • Chemical Class: Styrene derivative / tetrahydropyrimidine anthelmintic
  • Pharmacological Class: Anthelmintic
  • Primary Target: Parasitic nicotinic acetylcholine receptors
  • Therapeutic Area: Antiparasitic / veterinary medicine

PubChem specifically describes Oxantel as an anthelmintic that targets parasitic acetylcholine receptors and identifies Oxantel Pamoate as its pamoate salt.

Chemical Characteristics

Oxantel has a relatively low molecular weight of 216.28 g/mol and the molecular formula C13H16N2O. Its structure contains a phenolic hydroxyl group, a substituted pyrimidine ring and an E-configured ethenyl linkage. PubChem's preferred IUPAC name explicitly specifies the E configuration.

Oxantel Pamoate is substantially larger because it combines one oxantel molecule with one pamoic-acid component. Its formula is represented as C23H16O6·C13H16N2O, equivalent to C36H32N2O7, with a molecular weight of 604.6 g/mol.

Pharmacological Importance

Oxantel is an anthelmintic compound with activity associated with nematode neuromuscular signaling. Its pharmacological action is linked to interaction with parasite nicotinic acetylcholine receptors, resulting in disruption of normal neuromuscular function in susceptible parasites. PubChem classifies the compound as an anthelmintic and notes its relationship to pyrantel.

Oxantel Pamoate is particularly relevant to veterinary pharmaceutical formulations and has been used in combination products with other anthelmintic agents. Its pamoate salt provides a distinct pharmaceutical substance with different molecular weight and chemical identity from the Oxantel free base.

Oxantel Pamoate API

For pharmaceutical and commercial documentation, it is important to determine whether the intended product is Oxantel free base or Oxantel Pamoate.

The FDA Global Substance Registration System identifies Oxantel Pamoate as UNII UPY1D732T0 and lists 68813-55-8 among its identifiers. FDA also identifies Oxantel Pamoate as Oxantel Embonate, CP-14445-16, and Telopar.

The pamoate form is therefore the more relevant identity when preparing documentation for formulations specifically based on oxantel pamoate. Using the free-base molecular weight of 216.28 g/mol for an Oxantel Pamoate product would result in incorrect CMS information.

Pharmaceutical and Research Applications

Oxantel API can be relevant to:

  • Anthelmintic drug development
  • Veterinary pharmaceutical development
  • Nematode control formulations
  • Parasite receptor research
  • Nicotinic acetylcholine receptor studies
  • Antiparasitic formulation development
  • Pharmaceutical analytical testing
  • Reference-standard development
  • API quality-control research
  • Combination anthelmintic development

API Quality and Analytical Characterization

For a pharmaceutical-grade Oxantel API, identity and purity should be established using appropriate validated analytical procedures. Depending on the applicable specification, analytical characterization can include chromatographic assay, spectroscopic identity testing, related-substance determination, water determination, residual-solvent testing and other applicable quality attributes.

Publicly accessible authoritative sources reviewed for this page establish the chemical identity and molecular characteristics of Oxantel and Oxantel Pamoate, but do not establish a single universal numerical API release specification covering assay, related substances, loss on drying, heavy metals and residual solvents. Therefore, those fields are marked N/A below rather than using an unsupported specification.

Oxantel API Manufacturing Documentation

A commercial API technical package may include:

  • Certificate of Analysis
  • Product specification
  • Analytical method
  • HPLC chromatogram
  • IR spectrum
  • Related-substance profile
  • Residual-solvent data
  • Water-content data
  • Stability information
  • Safety Data Sheet
  • Batch analytical records

For CMS accuracy, the CAS number, salt form and molecular weight should always correspond to the exact material being offered.

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 0.2%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 0.5%
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