Description

Formoterol Ep Impurity C 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. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and quality control testing of respiratory medications.

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: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Formoterol-based formulations under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Formoterol.

Basic Information

Product Name	Formoterol Ep Impurity C
CAS No.	1795135-61-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Formoterol EP Impurity C; Formoterol Related Compound C; (R,R)-Formoterol Impurity C; 1-(3,5-Dihydroxyphenyl)-2-[(4-methoxybenzyl)amino]ethanol impurity; Formoterol Fumarate Impurity C; Formoterol Process Impurity C; 1795135-61-3
EINECS	Contact for details

Quality Control

Our Formoterol Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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