Description

Salmeterol Ep Impurity A CAS NO 1798014-51-3 is a high-purity chemical reference standard specifically used in the pharmaceutical development and quality control of Salmeterol, a long-acting beta2-adrenergic receptor agonist. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of Salmeterol-based drug products by enabling accurate identification and quantification during analytical testing. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, supporting activities from method development to batch release.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Salmeterol Ep Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Critical component for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Salmeterol.
• Quality Control and Batch Release Testing: Used in routine QC laboratories to monitor impurity profiles and ensure drug substance and product specifications meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Pharmacopeial Testing: Supports compliance testing as per monographs in the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.).

Basic Information

Product Name	Salmeterol Ep Impurity A
CAS No.	1798014-51-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Salmeterol Impurity A; Salmeterol Related Compound A; Salmeterol EP Impurity A; 4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol; (R,S)-Salmeterol Impurity A; Salmeterol Hydroxy Impurity; Salmeterol Process Impurity A
EINECS	Contact for details

Quality Control

Every batch of Salmeterol Ep Impurity A is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for identity, purity, and impurities. Our quality commitment aligns with the expectations of cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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