Description

Formoterol Impurity 55 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing formoterol fumarate, a long-acting β-agonist (LABA) used in asthma and COPD treatments. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in formoterol fumarate active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with regulatory specifications.
• Stability Studies: Utilized as a marker in forced degradation and long-term stability studies to track impurity formation and understand the degradation pathways of formoterol formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research and Development: Supports synthetic chemistry research aimed at understanding impurity formation mechanisms and developing improved purification processes for formoterol.

Basic Information

Product Name	Formoterol Impurity 55
CAS No.	71250-20-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Formoterol Related Compound; Formoterol Fumarate Impurity; Formoterol EP Impurity; Formoterol USP Impurity; (R,R)-Formoterol Impurity; 1-(3,5-Dihydroxyphenyl)-2-[(4-methoxybenzyl)amino]ethanol Impurity; 4-Methoxybenzyl Formoterol Derivative
EINECS	Contact for details

Quality Control

Every batch of Formoterol Impurity 55 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.