Description

Salmeterol Related Compound B (10 Mg) (4-{1-Hydroxy-2-[6-(4-Phenylbutan-2-Yloxy)Hexylamino]Ethyl}-2-(Hydroxymethyl)Phenol) is a high-purity reference standard critical for ensuring the quality and safety of pharmaceutical products. This compound, with CAS number 108928-81-0, is essential for analytical and research applications where precise identification and quantification are paramount. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in the development and production of respiratory medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, purity assessment, and quantification of Salmeterol and its related substances in active pharmaceutical ingredients (APIs) and finished drug products.
• Impurity Profiling and Control: Critical for method development and validation in HPLC and LC-MS analyses to monitor and control specified and unspecified impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development: Serves as a key component in developing and optimizing chromatographic methods for stability-indicating assays and forced degradation studies.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP, BP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough characterization and control of the drug substance.
• Research & Development: Used in preclinical and clinical research to study the metabolism, pharmacokinetics, and degradation pathways of Salmeterol.

Basic Information

Product Name	Salmeterol Related Compound B (10 Mg) (4-{1-Hydroxy-2-[6-(4-Phenylbutan-2-Yloxy)Hexylamino]Ethyl}-2-(Hydroxymethyl)Phenol)
CAS No.	108928-81-0
Molecular Formula	C25H37NO4
Molecular Weight	415.57 g/mol
Synonyms	4-{1-Hydroxy-2-[6-(4-Phenylbutan-2-Yloxy)Hexylamino]Ethyl}-2-(Hydroxymethyl)Phenol; Salmeterol Impurity B; Salmeterol EP Impurity B; Salmeterol Related Substance B; 1-Hydroxy-2-(6-(4-phenylbutoxy)hexylamino)ethyl]-2-(hydroxymethyl)phenol; Salmeterol Hydroxy Impurity; Salmeterol Analog B
EINECS	Contact for details

Quality Control

Our Salmeterol Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) are provided, detailing comprehensive test results against established specifications. We support compliance with cGMP, ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). Due to its sensitivity, the product should be handled under an inert atmosphere to prevent oxidation and stored in a dry environment to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
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.