Description

Salmeterol Impurity 10 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of Salmeterol Xinafoate, a long-acting β-agonist (LABA) medication. It serves as a key marker for identifying, quantifying, and controlling specific impurities during drug substance and drug product manufacturing. Pharmaceutical companies, analytical laboratories, and regulatory bodies require this impurity standard to meet stringent pharmacopeial guidelines and ensure batch-to-batch consistency.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Salmeterol Impurity 10 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to monitor impurity levels, ensuring every batch of Salmeterol Xinafoate meets predefined specification limits.
• Regulatory Submissions and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions (thermal, humidity, photolytic) as part of forced degradation and shelf-life studies.
• Research and Development: Aids in synthetic route optimization and process chemistry to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Salmeterol Impurity 10
CAS No.	129951-06-0
Molecular Formula	C25H37NO4
Molecular Weight	415.57 g/mol
Synonyms	1-(4-Hydroxy-3-(hydroxymethyl)phenyl)-2-((6-(4-phenylbutoxy)hexyl)amino)ethanol; Salmeterol Related Compound; Salmeterol EP Impurity; Salmeterol USP Impurity; 4-[1-Hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]-2-(hydroxymethyl)phenol; (RS)-Salmeterol Impurity 10; α-[[6-(4-Phenylbutoxy)hexyl]amino]methyl]-4-hydroxy-m-xylene-α,α'-diol
EINECS	Contact for details

Quality Control

Our Salmeterol Impurity 10 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results, chromatograms, and traceability information. Our quality standards are designed to support compliance with current Good Manufacturing Practice (cGMP) and relevant pharmacopeial monographs (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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