Description

Indacaterol Impurity 12 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Indacaterol, a long-acting beta2-adrenergic agonist (LABA). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining the stringent purity standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Indacaterol API and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Indacaterol products meet pharmacopeial specifications (e.g., USP, EP) for impurity limits.
• Stability Studies: Employed to identify and track degradation products that may form in Indacaterol formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Indacaterol Impurity 12
CAS No.	1026461-20-0
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 12; Indacaterol EP Impurity I; Indacaterol USP Impurity; (R)-5-(2-(tert-Butylamino)-1-hydroxyethyl)-8-hydroxy-1H-isochromen-1-one; UNII-9Z3I26B6QJ; Aclidinium Impurity (common misnomer); QAB149 Impurity 12
EINECS	Contact for details

Quality Control

Our Indacaterol Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data for full traceability. The material is suitable for use as a reference standard in compliance with ICH Q3A/B guidelines and major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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