Description

Formoterol Impurity 24 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Formoterol, a long-acting β-adrenoceptor agonist (LABA) medication. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance. The availability of this well-characterized impurity standard is essential for method validation and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Formoterol Impurity 24 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity characterization.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Research & Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and toxicological profile of Formoterol and related compounds.

Basic Information

Product Name	Formoterol Impurity 24
CAS No.	49861-92-9
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; Formamide, N-[2-hydroxy-5-[1-hydroxy-2-[(1-methyl-2-(4-methoxyphenyl)ethyl)amino]ethyl]phenyl]-; (R*,R*)-(±)-Formoterol Impurity 24; Formoterol Related Compound; Formoterol Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Formoterol Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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