Description

Formoterol Fumarate Dihydrate EP Impurity I is a specified impurity reference standard used in the analytical profiling and quality control of Formoterol Fumarate Dihydrate, a long-acting β-2 adrenergic agonist (LABA) active pharmaceutical ingredient (API). This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by providing a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of respiratory medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Formoterol Fumarate Dihydrate EP Impurity I in drug substance and drug product analysis.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) and Quality Assurance (QA): Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopoeial specifications (EP, USP) and ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
• Research and Development (R&D): Used in synthetic chemistry research to understand and control impurity formation pathways during API synthesis.

Basic Information

Product Name	Formoterol Fumarate Dihydrate EP Impurity I
CAS No.	532414-36-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Formoterol Fumarate Dihydrate Related Compound I; Formoterol Impurity I; (R,R)-Formoterol Fumarate Dihydrate Impurity; 1-(3-Formamido-4-hydroxyphenyl)-2-[4-(1-hydroxy-2-[[(4-methoxyphenyl)-1-methylethyl]amino]butyl]phenoxy]ethanol fumarate dihydrate; Atock Impurity I; Oxeze Impurity I; Foradil Impurity I
EINECS	Contact for details

Quality Control

Our high-purity reference standards are manufactured under strict quality management systems. Each batch of Formoterol Fumarate Dihydrate EP Impurity I undergoes rigorous identity confirmation, purity analysis, and impurity profiling to ensure it meets the exacting requirements for pharmaceutical impurity analysis. Certificates of Analysis (COA) are provided, detailing comprehensive analytical results from techniques such as HPLC, NMR, and MS. Our quality commitment aligns with the standards expected for materials used in GMP environments and regulatory submissions.

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 must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 10.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm

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