Description

Indacaterol Impurity 7 CAS NO 1403389-05-8 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Indacaterol. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Indacaterol drug substance and drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to accurately identify and quantify this specific impurity.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring every batch meets stringent purity specifications.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data and specifications for drug master files (DMFs).
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions, determining the shelf-life of the pharmaceutical product.
• Research and Development: Serves as a key intermediate or degradation product for studying the synthesis pathway, metabolism, and degradation profile of Indacaterol.

Basic Information

Product Name	Indacaterol Impurity 7
CAS No.	1403389-05-8
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; Indacaterol Related Compound 7; Indacaterol EP Impurity G; Indacaterol USP Impurity; Indacaterol Degradation Product; Onbrez Impurity 7; Arcapta Neohaler Impurity
EINECS	Contact for details

Quality Control

Every batch of Indacaterol Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

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%
Residual Solvents (GC)	Complies with ICH Q3C

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