Description

Indacaterol Impurity 20 is a high-purity chemical reference standard used in the development and quality control of pharmaceutical products. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Indacaterol, a long-acting beta2-adrenergic agonist (LABA). It is primarily required by pharmaceutical manufacturers and analytical laboratories for method validation, stability studies, and regulatory compliance. The availability of a well-characterized impurity standard is essential for maintaining stringent quality standards in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Indacaterol drug substance and drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to detect and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to identify and track the formation of degradation products in Indacaterol formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Supports synthetic route optimization and impurity profiling during the API development process.

Basic Information

Product Name	Indacaterol Impurity 20
CAS No.	1446354-20-6
Molecular Formula	C24H28N2O3
Molecular Weight	392.49 g/mol
Synonyms	5-[(1R)-2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one; Indacaterol Related Compound 20; Indacaterol EP Impurity J; UNII-7C4F8V9Q4I; (R)-5-(2-((5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-hydroxyethyl)-8-hydroxyquinolin-2(1H)-one
EINECS	Contact for details

Quality Control

Every batch of Indacaterol Impurity 20 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.