Description

Indacaterol Impurity 3 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Indacaterol, a long-acting beta2-adrenergic agonist (LABA) used in respiratory therapies. It is primarily utilized by analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing to identify, quantify, and monitor this specific impurity. Reliable access to well-characterized impurities like this is essential for regulatory compliance and maintaining the highest product quality standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Indacaterol Impurity 3 in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Indacaterol API and finished drug products meet stringent purity specifications.
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Used as a marker to monitor the formation of degradation products during drug stability testing under various conditions.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of the Indacaterol molecule during process development.

Basic Information

Product Name	Indacaterol Impurity 3
CAS No.	2250243-41-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-[(1R)-2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl]-8-hydroxy-1H-2-benzopyran-1-one Impurity; Indacaterol Related Compound 3; Indacaterol EP Impurity C; Indacaterol Process Impurity; (R)-5-(2-(tert-Butylamino)-1-hydroxyethyl)-8-hydroxy-1H-isochromen-1-one Impurity
EINECS	Contact for details

Quality Control

Every batch of Indacaterol Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including those relevant to pharmaceutical reference materials. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions recommended for light-sensitive organic compounds.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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