Active Pharmaceutical Ingredient

Indacaterol

Also known as: Onbrez / Arcapta / Breezhaler

CAS: 312753-06-3 Ultra-LABA / Beta-2 Agonist IP / BP / EP / USP Bulk Supply Available
Indacaterol API Manufacturer India | Mediocon Inc
Indacaterol — Pharmaceutical Grade API

Product Overview

CAS No: 312753-06-3  |  MF: C₂₄H₂₈N₂O₃  |  MW: 392.49 g/mol

Indacaterol is an ultra-long-acting beta-2 adrenergic agonist (ultra-LABA) used for maintenance bronchodilation in COPD. A single daily inhalation provides 24-hour bronchodilation. Mediocon Inc supplies pharmaceutical-grade Indacaterol Maleate API meeting IP/BP/EP/USP standards for inhalation formulations.

Key Features

  • Ultra-long-acting beta-2 agonist (once-daily)
  • IP/BP/EP/USP compliant quality
  • 24-hour bronchodilation in COPD
  • Micronized grade for DPI formulations

Applications

  • COPD (chronic obstructive pulmonary disease)
  • Maintenance bronchodilation therapy
  • Dry powder inhaler (DPI) formulations
  • Combination therapy with glycopyrronium

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameIndacaterol
Also Known AsOnbrez / Arcapta / Breezhaler
CAS Number312753-06-3
Molecular FormulaC₂₄H₂₈N₂O₃
Molecular Weight392.49 g/mol
CategoryUltra-LABA / Beta-2 Agonist
AppearanceWhite to Off-white Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 1.0%
Heavy MetalsNMT 20 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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