Description

Formoterol-Impurity-B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a key impurity marker in the analysis of Formoterol fumarate. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of impurities in Formoterol fumarate drug substances and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Acts as a system suitability standard in routine QC testing to ensure the accuracy and precision of analytical procedures.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Formoterol formulations under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances in biological systems.

Basic Information

Product Name	Formoterol-Impurity-B
CAS No.	1224588-66-2
Molecular Formula	C19H24N2O4
Molecular Weight	344.41 g/mol
Synonyms	N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Formoterol Related Compound B; Formoterol EP Impurity B; (R*,R*)-(±)-N-[2-Hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Formamide, N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-
EINECS	Contact for details

Quality Control

Our Formoterol-Impurity-B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and research needs. The material is suitable for use as a reference standard in compliance with ICH and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

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)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.