Description

Indacaterol Impurity 13 (Mixture Of Diastereomers) is a defined chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) indacaterol maleate. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in the research, development, and commercial production of respiratory medications, serving as a key marker for process optimization and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical equipment (HPLC, LC-MS) in the quality control of Indacaterol API and finished drug products.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Stability Indicating Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Indacaterol formulations.
• Process Chemistry Research: Acts as a marker to understand and control synthetic pathways, helping to minimize impurity formation during the API manufacturing process.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Pharmacopoeial Testing: Supports testing against monographs in pharmacopoeias such as USP or EP where impurity profiling is required.

Basic Information

Product Name	Indacaterol Impurity 13 (Mixture Of Diastereomers)
CAS No.	1446354-19-3
Molecular Formula	C24H28N2O3
Molecular Weight	392.49 g/mol
Synonyms	5-[(1R)-2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl]-8-hydroxy-1H-2-benzopyran-1-one Impurity 13; Indacaterol Related Compound 13; (R)-5-(2-(tert-Butylamino)-1-hydroxyethyl)-8-hydroxy-1H-isochromen-1-one Diastereomeric Mixture; UNII-9F6T8I8Q0G; Indacaterol EP Impurity G; Indacaterol Diastereomer Impurity.
EINECS	Contact for details

Quality Control

Every batch of Indacaterol Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and residual solvents as applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the container should be kept in a dry environment and allowed to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 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.