Active Pharmaceutical Ingredient

Setastine — CAS 116476-13-2

Also known as: Setastine Base

GMP Certified IP / BP / EP / USP Antihistamine / H1 Receptor Antagonist Aurangabad, India
Setastine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Setastine IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 116476-13-2

Product Overview

Setastine is a second-generation antihistamine with potent H1-receptor antagonist activity used for the symptomatic relief of allergic conditions. It demonstrates low CNS penetration, resulting in minimal sedation compared to classical antihistamines. Setastine is effective in managing urticaria, allergic rhinitis, and other IgE-mediated hypersensitivity reactions. Mediocon Inc manufactures GMP-certified Setastine API at its Aurangabad facility.

Therapeutic Applications
  • Allergic rhinitis
  • Urticaria and skin allergies
  • IgE-mediated hypersensitivity
  • Non-sedating antihistamine formulations

Technical Specifications

ParameterSpecification
CAS Number116476-13-2
Molecular FormulaC₂₁H₂₄ClN₃
Molecular Weight357.89 g/mol
GradeIP / BP / EP / USP
CategoryAntihistamine / H1 Receptor Antagonist
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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