Description

Atomoxetine Ep Impurity A is a designated reference standard used in the pharmaceutical development and quality control of Atomoxetine Hydrochloride, a medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing in compliance with pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Atomoxetine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating precise HPLC, UPLC, or GC analytical methods to monitor impurity profiles.
• Quality Control and Batch Release: Used in routine QC testing to ensure drug substance and product batches meet stringent purity specifications, typically as per EP or USP monographs.
• Stability Studies: Employed to identify and track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate control strategies for known and potential impurities.
• Research and Development: Utilized in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize impurity formation.

Basic Information

Item	Detail
Product Name	Atomoxetine Ep Impurity A
CAS No.	873310-33-9
Molecular Formula	C17H21NO
Molecular Weight	255.36 g/mol
Synonyms	N-Methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine; (R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine; Atomoxetine Related Compound A; Atomoxetine Impurity A; (R)-Atomoxetine Impurity A; Tomoxetine Impurity A; LY139603 Impurity A
EINECS	Contact for details

Quality Control

Every batch of Atomoxetine Ep Impurity A is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identification (IR, NMR), residual solvents, and water content (KF). Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C, in a dry environment. Keep the container sealed to protect the material from moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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