Description

Atomoxetine Impurity 15 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Atomoxetine HCl, the active ingredient in the medication used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing of the drug substance and finished products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Atomoxetine Impurity 15 in Atomoxetine HCl active pharmaceutical ingredient (API) and related drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure compliance with stringent pharmacopeial (e.g., USP, EP, ICH) guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of the drug substance.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Atomoxetine under various conditions.

Basic Information

Product Name	Atomoxetine Impurity 15
CAS No.	881995-45-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atomoxetine Related Compound 15; Atomoxetine EP Impurity G; Atomoxetine USP Impurity; (3R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine Impurity; Tomoxetine Impurity 15; LY139603 Impurity
EINECS	Contact for details

Quality Control

Our Atomoxetine Impurity 15 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, aligning with current pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results for identity, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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