Description

Fenoterol Degradation Impurity A is a specified impurity and degradation product of the β-2 adrenergic agonist, Fenoterol Hydrobromide. This compound is critically important for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control. It is essential for laboratories and manufacturers involved in the synthesis, purification, and regulatory compliance of Fenoterol-based drug substances and products, ensuring product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Fenoterol-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor degradation pathways.
• Stability and Forced Degradation Studies: Used to understand the degradation profile of Fenoterol under various stress conditions (e.g., heat, light, humidity, acid/base) as per ICH guidelines.
• Quality Control & Batch Release Testing: Acts as a system suitability standard and impurity marker in the routine QC testing of Fenoterol Hydrobromide to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Regulatory Submissions: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data and specifications for drug master files.
• Research on Degradation Mechanisms: Facilitates chemical research aimed at elucidating the specific pathways and kinetics of Fenoterol degradation.

Basic Information

Product Name	Fenoterol Degradation Impurity A
CAS No.	161040-25-1
Molecular Formula	C17H21NO4
Molecular Weight	303.36 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-[[(4-hydroxyphenyl)-1-methylethyl]amino]ethanol; 4-Hydroxy-α-[[(4-hydroxyphenyl)-1-methylethyl]amino]methyl]-1,3-benzenedimethanol; Fenoterol Impurity A; Fenoterol Related Compound A; Fenoterol EP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Fenoterol Degradation Impurity A is manufactured and analyzed under strict quality management systems. It is characterized using advanced spectroscopic and chromatographic techniques (NMR, MS, HPLC) to ensure structural identity and high purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, impurity profile, and analytical results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to maximize 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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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