Description

Salmeterol Impurity CAS NO 144391-74-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Salmeterol, a long-acting beta2-adrenergic agonist. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and control related substances in Salmeterol Xinafoate API and its finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to confirm product purity and compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Used as a marker to monitor the formation of degradation products in Salmeterol formulations under various stress conditions.
• Research & Development: Facilitates chemical and metabolic pathway studies in academic and industrial R&D settings focused on respiratory therapeutics.

Basic Information

Product Name	Salmeterol Impurity
CAS No.	144391-74-2
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; (±)-Salmeterol
EINECS	Contact for details

Quality Control

Every batch of Salmeterol Impurity (CAS 144391-74-2) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ISO, and other relevant regulatory frameworks for pharmaceutical reference standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
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
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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