Epinastine Hydrochloride API Manufacturer & Supplier in India

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

Epinastine Hydrochloride API

Epinastine Hydrochloride is the hydrochloride salt of Epinastine, a second-generation histamine H1 receptor antagonist with antiallergic activity. It inhibits histamine-mediated allergic responses and also suppresses the release of histamine from mast cells.

Epinastine Hydrochloride is used in pharmaceutical products for the management of allergic conditions, particularly allergic conjunctivitis. Epinastine has also been described as having affinity for H2, 5-HT2 and alpha-adrenergic receptors.

What is Epinastine Hydrochloride?

Epinastine Hydrochloride is a synthetic antihistamine and antiallergic pharmaceutical ingredient. The hydrochloride salt has the molecular formula C₁₆H₁₆ClN₃, molecular weight 285.77 g/mol, and CAS number 108929-04-0.

It is also known as Epinastine HCl, Epinastine Hydrochloride, WAL-801CL, and WAL 801 CL.

Epinastine Hydrochloride API Manufacturer & Supplier

Swapnroop Drugs and Pharmaceuticals provides Epinastine Hydrochloride for qualified pharmaceutical manufacturing, formulation development, research and pharmaceutical sourcing requirements.

Epinastine Hydrochloride is a specialized antihistamine API suitable for pharmaceutical applications involving allergic and ophthalmic formulations.

Mechanism of Action

Epinastine Hydrochloride acts primarily as a histamine H1 receptor antagonist. By blocking H1 receptors, it reduces the effects of histamine responsible for allergic symptoms. It also inhibits histamine release from mast cells, providing an additional antiallergic mechanism.

Pharmaceutical Applications

Epinastine Hydrochloride is associated with:

  • Allergic conjunctivitis
  • Ophthalmic antiallergic formulations
  • H1 antihistamine research
  • Allergy pharmaceutical development
  • Histamine receptor research
  • Mast-cell stabilization research
  • Antiallergic drug development
  • Pharmaceutical formulation development

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%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point 168°C – 172°C
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