Description

Salmeterol Impurity 9 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Salmeterol. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development and production of respiratory medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Salmeterol Impurity 9 in drug substances and products.
• Analytical Method Development: Used in HPLC, UPLC, and GC method development to establish specificity, accuracy, and detection limits.
• Quality Control & Assurance: Essential for routine batch testing in GMP environments to monitor and control impurity profiles.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions and over shelf life.
• Research & Development: Used in synthetic chemistry research to understand and optimize the Salmeterol synthesis pathway.

Basic Information

Product Name	Salmeterol Impurity 9
CAS No.	97664-58-9
Molecular Formula	C25H37NO4
Molecular Weight	415.57 g/mol
Synonyms	1-(4-Hydroxy-3-(hydroxymethyl)phenyl)-2-((6-(4-phenylbutoxy)hexyl)amino)ethanol; Salmeterol Related Compound; Salmeterol EP Impurity; Salmeterol USP Impurity; 4-[1-Hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]-2-(hydroxymethyl)phenol
EINECS	Contact for details

Quality Control

Every batch of Salmeterol Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

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 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.