Description

Arformoterol Impurity 24 is a high-purity reference standard used in the pharmaceutical development and quality control of Arformoterol, a long-acting beta2-adrenergic receptor agonist. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a key marker for identification and quantification of related substances. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Arformoterol Impurity 24 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the Arformoterol API.

Basic Information

Product Name	Arformoterol Impurity 24
CAS No.	477552-93-5
Molecular Formula	C19H24N2O4
Molecular Weight	344.41 g/mol
Synonyms	Arformoterol Related Compound 24; (R,R)-Formoterol Impurity 24; (R,R)-N-[2-Hydroxy-5-[(1R)-1-hydroxy-2-[[(2R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Arformoterol EP Impurity I; Arformoterol USP Impurity; Brovana Impurity
EINECS	Contact for details

Quality Control

Every batch of Arformoterol Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 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.