Description

Atomoxetine Ep Impurity A is a specified impurity and reference standard used in the analytical profiling and quality control of Atomoxetine Hydrochloride, the active pharmaceutical ingredient in a non-stimulant medication for Attention Deficit Hyperactivity Disorder (ADHD). This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is primarily utilized in research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Atomoxetine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure API and drug products meet specifications for impurity limits as per ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., light, heat, humidity) to establish product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Pharmacopeial Testing: Specifically required for testing against European Pharmacopoeia (EP) monographs for Atomoxetine Hydrochloride.

Basic Information

Product Name	Atomoxetine Ep Impurity A
CAS No.	56161-70-7
Molecular Formula	C17H21NO
Molecular Weight	255.36 g/mol
Synonyms	N-Methyl-3-phenyl-3-(o-tolyloxy)propylamine; (R)-N-Methyl-3-phenyl-3-(2-methylphenoxy)propan-1-amine; Atomoxetine Related Compound A; Atomoxetine Impurity A; (R)-Tomoxetine Impurity A; LY139603 Impurity A; (3R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine
EINECS	Contact for details

Quality Control

Our Atomoxetine Ep Impurity A is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters. Our quality system is designed to support compliance with cGMP and relevant pharmacopeial standards (EP, USP) for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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