Description

Formoterol Ep Impurity D is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Formoterol fumarate, a widely used bronchodilator. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Formoterol fumarate drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize synthesis processes to minimize impurity formation.

Basic Information

Product Name	Formoterol Ep Impurity D
CAS No.	1795133-96-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Formoterol Impurity D; Formoterol Related Compound D; Formoterol EP Impurity D; (R,R)-Formoterol Impurity; 1-(3,5-Dihydroxyphenyl)-2-[(4-methoxybenzyl)amino]ethanol impurity; Formoterol Fumarate Impurity D; Formoterol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Formoterol Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles.

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 kept in a desiccated environment to maintain stability and purity. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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