Description

Formoterol Impurity 28 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 pharmaceutical products containing formoterol fumarate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining the highest standards in drug development and quality control.

Application

• Pharmaceutical Reference Standard: 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 & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP, ICH).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used to track the formation of degradation products in stability testing of formoterol-based formulations.
• Research & Development: Serves as a key material in pharmaceutical R&D for studying the metabolism, degradation pathways, and synthesis of formoterol.

Basic Information

Product Name	Formoterol Impurity 28
CAS No.	67346-67-2
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; Formoterol EP Impurity; Formoterol USP Impurity; (RS)-N-[2-Hydroxy-5-[(RS)-1-hydroxy-2-[[(RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; (±)-N-[2-Hydroxy-5-[(±)-1-hydroxy-2-[[(±)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide
EINECS	Contact for details

Quality Control

Every batch of Formoterol Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced techniques such as HPLC, GC, MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and chromatographic profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

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)	Total impurities ≤ 2.0% Any single unknown 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.