Description

Salmeterol Ep Impurity F CAS NO 1391054-40-2 is a high-purity chemical reference standard specifically identified as a key impurity in the synthesis and quality control of Salmeterol Xinafoate, a long-acting beta2-adrenergic agonist. This compound is critical for pharmaceutical research and development, enabling precise analytical method development and validation to ensure drug safety and efficacy. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals within the global pharmaceutical and contract research organization (CRO) sectors to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Salmeterol Ep Impurity F in Salmeterol Xinafoate Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Used to develop, optimize, and validate High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure API and drug product purity complies with International Council for Harmonisation (ICH), United States Pharmacopeia (USP), and European Pharmacopoeia (EP) guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to monitor impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids in understanding and optimizing the Salmeterol synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Salmeterol Ep Impurity F
CAS No.	1391054-40-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Salmeterol Impurity F; Salmeterol Related Compound F; 4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol (potential structural descriptor); Salmeterol Xinafoate Impurity F; Salmeterol EP Impurity F; Salmeterol Process Impurity F; Salmeterol Analog F
EINECS	Contact for details

Quality Control

Every batch of Salmeterol Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality documentation.

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 the container with care to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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