Description

Rac-Atomoxetine Ep Impurity C is a key chemical reference standard used in the analytical profiling and quality control of Atomoxetine, a non-stimulant medication for attention deficit hyperactivity disorder (ADHD). This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a certified reference material in the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of related substances in Atomoxetine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Academic & Contract Research: Supports chemical and pharmacological research related to ADHD therapeutics and stereochemistry.

Basic Information

Product Name	Rac-Atomoxetine Ep Impurity C
CAS No.	56161-78-5
Molecular Formula	C17H21NO
Molecular Weight	255.36 g/mol
Synonyms	(±)-N-Methyl-3-phenyl-3-(o-tolyloxy)propylamine; (R,S)-N-Methyl-3-phenyl-3-(2-methylphenoxy)propan-1-amine; Atomoxetine Racemic Impurity C; Atomoxetine EP Impurity C; Tomoxetine Impurity C; LY139603 Impurity; (RS)-Tomoxetine Impurity C
EINECS	Contact for details

Quality Control

Every batch of Rac-Atomoxetine Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for assay, related substances, residual solvents, and identification is provided with each 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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 98.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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