Lodoxamide API Manufacturer in India

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

Lodoxamide API

Lodoxamide is a mast-cell stabilizer used primarily as an ophthalmic antiallergic agent. It inhibits the release of inflammatory mediators from mast cells and is used in the management of allergic eye conditions, including vernal keratoconjunctivitis.

Lodoxamide is particularly associated with stabilizing mast-cell membranes and preventing the release of histamine and other inflammatory mediators involved in ocular allergic responses.

Lodoxamide API Manufacturer in India

Lodoxamide is a specialized ophthalmic pharmaceutical API used in the development and manufacture of antiallergic eye-drop formulations.

Important quality attributes include identity, assay, related substances, water content, residue on ignition, heavy metals, residual solvents and particle characteristics.

Chemical Information

CAS Number: 53866-97-0
Molecular Formula: C11H6ClN3O2
Molecular Weight: 247.64 g/mol
Chemical Name: N-(3,4-dichlorophenyl)-N′-[2-(2,4-dioxo-1,3-imidazolidinyl)ethyl]oxamide
Drug Class: Mast Cell Stabilizer
Therapeutic Class: Ophthalmic Antiallergic
Therapeutic Area: Ophthalmology / Allergy
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Lodoxamide acts primarily as a mast-cell stabilizer. It inhibits antigen-induced mast-cell degranulation and reduces the release of inflammatory mediators involved in allergic reactions.

By limiting mediator release, Lodoxamide helps reduce ocular manifestations associated with allergic inflammation.

Pharmaceutical Applications

Lodoxamide API is used in pharmaceutical formulations for:

  • Allergic conjunctivitis
  • Vernal keratoconjunctivitis
  • Ocular allergic inflammation
  • Mast-cell stabilization research
  • Ophthalmic antiallergic formulations
  • Ocular inflammation research

Ophthalmic Applications

Lodoxamide is formulated as an ophthalmic solution for topical administration to the eye. Its mast-cell-stabilizing properties make it useful for controlling allergic ocular symptoms.

Physical Characteristics

Lodoxamide is a white to off-white crystalline solid/powder. It has limited aqueous solubility, and pharmaceutical formulations use appropriate formulation techniques to achieve the required concentration and stability.

Manufacturing Process

A controlled Lodoxamide API manufacturing process may involve:

  1. Preparation of qualified starting materials
  2. Synthesis of substituted aromatic intermediates
  3. Preparation of the imidazolidinedione intermediate
  4. Controlled coupling reactions
  5. Purification
  6. Crystallization
  7. Filtration
  8. Drying
  9. Milling, where required
  10. Final analytical testing
  11. GMP-compliant packaging

Quality Control Testing

Typical Lodoxamide API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Water content
  • Residue on ignition
  • Heavy metals
  • Residual solvents
  • Melting point
  • Particle-size distribution where applicable
  • Stability testing

Storage

Store Lodoxamide API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should follow validated stability data.

Pharmaceutical Research

Lodoxamide is relevant to research involving:

  • Mast-cell stabilization
  • Histamine release
  • Allergic inflammation
  • Ocular allergy
  • Vernal keratoconjunctivitis
  • Ophthalmic drug development
  • Antiallergic agents
  • Mast-cell mediator release
  • Ocular pharmaceutical formulations

Lodoxamide API Summary

Lodoxamide is a mast-cell stabilizing ophthalmic API with CAS Number 53866-97-0, molecular formula C11H6ClN3O2, and molecular weight 247.64 g/mol. It is primarily associated with ophthalmic antiallergic formulations and works by inhibiting mast-cell mediator release.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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