Description

Atomoxetine Impurity CAS NO 42064-62-0 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities during the manufacturing of Atomoxetine HCl, a non-stimulant medication used to treat ADHD. It is primarily required by analytical laboratories and quality control units within the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance. The availability of this well-characterized impurity supports method validation and stability studies, which are fundamental to modern Good Manufacturing Practice (GMP).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Impurity Profiling and Identification: Used to identify and quantify this specific impurity in Atomoxetine HCl active pharmaceutical ingredient (API) batches to meet ICH Q3A/B guidelines.
• Method Development and Validation: A critical component in developing and validating HPLC, UPLC, or GC methods for impurity detection and separation.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation and ensure drug product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies.
• Research and Development: Used in synthetic chemistry R&D to study reaction pathways and optimize processes to minimize impurity formation.

Basic Information

Product Name	Atomoxetine Impurity
CAS No.	42064-62-0
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; Tomoxetine Impurity; LY139603 Impurity; Atomoxetine Related Compound; (3R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine
EINECS	Contact for details

Quality Control

Every batch of Atomoxetine Impurity CAS NO 42064-62-0 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with ICH guidelines and can supply materials suitable for use under GMP conditions for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under an inert atmosphere, please contact our technical team for specific recommendations.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.