Active Pharmaceutical Ingredient

Indacaterol Maleate

Also known as: Onbrez; Arcapta Neohaler

CAS: 753498-25-8 Ultra-LABA IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Indacaterol Maleate API — Mediocon Inc
Indacaterol Maleate — Pharmaceutical Grade API

Product Overview

CAS No: 753498-25-8  |  MF: C₂₄H₂₈N₂O₃·C₄H₄O₄  |  MW: 508.56 g/mol

Indacaterol Maleate is an ultra-long-acting beta-2 adrenergic agonist (ultra-LABA) used as an active pharmaceutical ingredient. Mediocon Inc supplies high-purity Indacaterol Maleate API conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Indacaterol Maleate provides once-daily bronchodilation for the maintenance treatment of airflow limitation in adults with COPD. Its ultra-long-acting profile (24+ hours) makes it ideal for improved patient compliance.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Once-daily COPD maintenance therapy
  • Bronchodilation in chronic airway obstruction
  • Fixed-dose combinations with LAMAs
  • Respiratory disease management

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 Maleate
Also Known AsOnbrez; Arcapta Neohaler
CAS Number753498-25-8
Molecular FormulaC₂₄H₂₈N₂O₃·C₄H₄O₄
Molecular Weight508.56 g/mol
CategoryUltra-LABA — Bronchodilator
AppearanceWhite to yellowish crystalline powder
SolubilitySlightly soluble in water; soluble in methanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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