Description

Formoterol Impurity 13 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 the active pharmaceutical ingredient (API) Formoterol Fumarate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Formoterol Fumarate API and its drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities during API synthesis.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine batch release testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress and long-term storage conditions.
• Research & Development (R&D): Used in synthetic chemistry research to study degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Formoterol Impurity 13
CAS No.	150513-24-9
Molecular Formula	C19H24N2O4
Molecular Weight	344.41 g/mol
Synonyms	Formoterol Related Compound; Formoterol Fumarate Impurity; (R*,R*)-(±)-N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Formamide, N-[2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-; Formoterol EP Impurity C; Formoterol USP Impurity
EINECS	Contact for details

Quality Control

Our Formoterol Impurity 13 is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant standards for pharmaceutical impurities.

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 to prevent potential degradation.

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%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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