Description

Salmeterol Ep Impurity D is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the pharmaceutical development of Salmeterol, a long-acting beta2-adrenergic agonist. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing to ensure product purity and safety.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Salmeterol Xinafoate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity profiling and stability studies for drug substances and products.
• Pharmacopeial Testing: Employed in testing to meet the stringent impurity limits specified in pharmacopeial monographs (e.g., USP, EP, BP).
• Stability Studies: Used to monitor the formation of this specific impurity over time under various stress conditions to establish shelf-life and storage recommendations.
• Academic & Contract Research: Serves as a key reagent in university and CRO settings for research into the synthesis, degradation pathways, and metabolism of Salmeterol.

Basic Information

Product Name	Salmeterol Ep Impurity D
CAS No.	1391052-04-2
Molecular Formula	C25H37NO4
Molecular Weight	415.57 g/mol
Synonyms	Salmeterol EP Impurity D; Salmeterol Impurity D; 4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol; (R)-Salmeterol EP Impurity D; Salmeterol Related Compound D; Salmeterol Xinafoate Impurity D; 1-[4-Hydroxy-3-(hydroxymethyl)phenyl]-2-[[6-[4-(phenyl)butoxy]hexyl]amino]ethanol
EINECS	Contact for details

Quality Control

Every batch of Salmeterol Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and 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, cool place. This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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.