Levamisole API | Anthelmintic & Immunomodulator API Manufacturer in India

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Levamisole API

Levamisole is a synthetic imidazothiazole derivative with anthelmintic and immunomodulatory properties. It acts primarily on nicotinic acetylcholine receptors of susceptible nematodes, causing sustained neuromuscular activation, paralysis and eventual elimination of the parasites.

Levamisole has been used as an anthelmintic in veterinary medicine and has also had historical applications in human medicine as an immunomodulatory agent.

Levamisole API Manufacturer in India

Levamisole is a specialized pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.

Important quality attributes include identity, assay, related substances, stereochemical purity, water content, residual solvents, elemental impurities and stability.

Chemical Information

CAS Number: 14769-73-4
Molecular Formula: C11H12N2S
Molecular Weight: 204.29 g/mol
Drug Class: Anthelmintic / Immunomodulator
Pharmacological Class: Imidazothiazole Anthelmintic
Therapeutic Class: Antiparasitic Agent
Therapeutic Area: Parasitology / Veterinary Medicine

Mechanism of Action

Levamisole acts on nicotinic acetylcholine receptors in nematode parasites.

This produces persistent stimulation of the parasite's neuromuscular system, resulting in:

  • Neuromuscular depolarization
  • Spastic paralysis of susceptible worms
  • Immobilization of parasites
  • Elimination of the parasite from the host

Levamisole also has immunomodulatory activity, although its immunological mechanism is distinct from its anthelmintic action.

Pharmaceutical Applications

Levamisole has been used primarily as an anthelmintic for susceptible nematode infections, particularly in veterinary medicine.

Historically, it was also used in certain human therapeutic settings, although its human use has become limited in many markets because of safety concerns and the availability of alternative treatments.

Imidazothiazole Characteristics

Levamisole belongs to the imidazothiazole class of anthelmintic compounds. It is the pharmacologically active levorotatory isomer associated with the anthelmintic activity of the compound.

Its stereochemical purity is therefore an important quality attribute for pharmaceutical manufacturing.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of substituted thiazole intermediates
  2. Construction of the imidazothiazole ring system
  3. Controlled chemical transformations
  4. Stereochemical control
  5. Purification
  6. Crystallization
  7. Filtration
  8. Drying
  9. Milling where required
  10. Final analytical testing
  11. Controlled packaging

Quality and Analytical Testing

Levamisole API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Mass spectrometry
  • Assay
  • Related substances
  • Stereochemical purity
  • Optical rotation
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Particle-size distribution where required
  • Stability testing

Storage

Levamisole should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established through validated stability studies.

Pharmaceutical Research and Development

Levamisole is relevant to research involving:

  • Anthelmintic agents
  • Nematode parasites
  • Nicotinic acetylcholine receptors
  • Imidazothiazole compounds
  • Parasite neuromuscular pharmacology
  • Veterinary pharmaceuticals
  • Immunomodulation
  • Antiparasitic drug development

Levamisole API Summary

Levamisole is an imidazothiazole anthelmintic with CAS Number 14769-73-4, molecular formula C11H12N2S, and molecular weight 204.29 g/mol. It acts primarily through nicotinic acetylcholine receptors in susceptible nematodes, producing neuromuscular paralysis and parasite elimination.

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 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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