Description

Salmeterol Ep Impurity G CAS NO 1391051-88-9 is a high-purity reference standard specifically used in the analytical profiling of Salmeterol, a long-acting beta2-adrenergic agonist (LABA) medication. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a defined marker to ensure the purity and safety of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Salmeterol API and its formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor process-related impurities.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure Salmeterol drug substances and products meet pharmacopoeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (forced degradation studies) to establish shelf life.
• Regulatory Documentation & Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research on Drug Degradation Pathways: Aids in research to understand the chemical stability and degradation mechanisms of Salmeterol.

Basic Information

Product Name	Salmeterol Ep Impurity G
CAS No.	1391051-88-9
Molecular Formula	C25H37NO4
Molecular Weight	415.57 g/mol
Synonyms	1-[4-Hydroxy-3-(hydroxymethyl)phenyl]-2-{[6-(4-phenylbutoxy)hexyl]amino}ethanol; Salmeterol Impurity G; Salmeterol Related Compound G; Salmeterol EP Impurity G; Salmeterol USP Impurity G; Salmeterol Process Impurity; (RS)-Salmeterol Impurity G; 4-[1-Hydroxy-2-[[6-(4-phenylbutoxy)hexyl]amino]ethyl]-2-(hydroxymethyl)phenol
EINECS	Contact for details

Quality Control

Every batch of Salmeterol Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality needs.

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 COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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