Description

Formoterol Impurity 27 is a high-purity 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 precise characterization of this impurity is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of formoterol fumarate drug substances and products.
• Impurity Profiling & Identification: Essential for identifying and quantifying Formoterol Impurity 27 in active pharmaceutical ingredients (APIs) during stability studies and batch release testing.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in in-house quality control laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and control strategies.
• Research & Development (R&D): Used in pharmaceutical R&D to study the degradation pathways and stability profile of formoterol-based formulations.

Basic Information

Product Name	Formoterol Impurity 27
CAS No.	245759-66-4
Molecular Formula	C19H24N2O4
Molecular Weight	344.41 g/mol
Synonyms	Formoterol Related Compound; Formoterol EP Impurity; (R,R)-Formoterol Impurity; N-[2-Hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-; Arformoterol Impurity; Oxeze Impurity
EINECS	Contact for details

Quality Control

Every batch of Formoterol Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure compliance with relevant pharmacopeial standards (e.g., USP, EP) and ICH guidelines for impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and related substances by validated chromatographic methods.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.1%

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