Description

Indacaterol Impurity 22 is a designated impurity standard of the long-acting β-2 adrenergic agonist, Indacaterol. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Indacaterol API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish system suitability, specificity, and detection limits.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Process Chemistry Optimization: Helps in identifying and controlling process-related impurities during the synthesis and scale-up of Indacaterol.

Basic Information

Item	Detail
Product Name	Indacaterol Impurity 22
CAS No.	773895-24-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 22; Indacaterol EP Impurity H; Indacaterol Impurity H; UNII-8Q0B6K7V4R
EINECS	Contact for details

Quality Control

Our Indacaterol Impurity 22 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed to prevent moisture absorption.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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