Description

Formoterol Ep Impurity F CAS NO 1795129-59-7 is a high-purity chemical reference standard specifically identified as a process-related impurity of Formoterol. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity during the analysis of Formoterol Fumarate API.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control and Batch Release Testing: Employed as a system suitability standard and for preparing calibration curves in the routine QC testing of Formoterol drug substances and finished dosage forms.
• Stability Studies and Forced Degradation Testing: Acts as a reference to monitor the formation of this impurity under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) requirements.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate control strategies for known impurities, supporting FDA, EMA, and other health authority approvals.
• Research on Synthetic Pathways: Useful for chemists in process research to understand and optimize the synthesis of Formoterol, helping to minimize the formation of this by-product.

Basic Information

Product Name	Formoterol Ep Impurity F
CAS No.	1795129-59-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Formoterol Related Compound F; Formoterol Impurity F; Formoterol EP Impurity F; (R,R)-Formoterol Impurity; 1-(3,5-Dihydroxyphenyl)-2-[(4-methoxybenzyl)amino]ethanol impurity; Formoterol Process Impurity; Formoterol Fumarate Impurity F
EINECS	Contact for details

Quality Control

Every batch of Formoterol Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (EP, USP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment and is available upon request.

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 under inert atmosphere or in a desiccator to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to Reference Standard
Identification (IR)	Conforms to Structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual Unknown Impurity: ≤ 0.5% Total Impurities: ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C Guidelines
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)

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