Description

Formoterol Ep Impurity E is a high-purity reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of drug products by accurately identifying and quantifying process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of respiratory medications containing formoterol.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Formoterol Fumarate and related drug substances.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for the identification, characterization, and quantification of this specific epimeric impurity during stability studies and forced degradation studies.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry Optimization: Employed by R&D and manufacturing teams to monitor and minimize the formation of this impurity during the synthesis and purification stages of the active pharmaceutical ingredient (API).
• Pharmacopoeial Testing: Used as a system suitability component in testing to comply with pharmacopoeial monographs (e.g., USP, EP, BP) for formoterol-containing products.

Basic Information

Product Name	Formoterol Ep Impurity E
CAS No.	1616967-26-0
Molecular Formula	C19H24N2O4
Molecular Weight	344.41 g/mol
Synonyms	Formoterol Impurity E; Formoterol EP Impurity E; (R,R)-Formoterol; (R,R)-N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; 1,3-Benzenediol, 4-hydroxy-α-[[[2-(4-methoxyphenyl)-1-methylethyl]amino]methyl]-, (αR,1R)-; Formoterol Diastereomer E
EINECS	Contact for details

Quality Control

Every batch of Formoterol Ep Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, GC, MS, and NMR to confirm identity and ensure high purity levels suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your quality and regulatory requirements.

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 (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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