Description

Atomoxetine Impurity D is a specified impurity of the active pharmaceutical ingredient Atomoxetine Hydrochloride, used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this impurity during drug substance and drug product manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for qualitative and quantitative analysis in HPLC, LC-MS, and GC methods.
• Method Development and Validation: Critical for developing and validating analytical procedures to detect and quantify Atomoxetine Impurity D in accordance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity profiles of Atomoxetine Hydrochloride drug substance and finished dosage forms.
• Stability Studies: Employed as a marker to assess the degradation pathways and stability of Atomoxetine formulations under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Research and Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during synthesis.

Basic Information

Product Name	Atomoxetine Impurity D
CAS No.	1643684-02-9
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 D; Atomoxetine EP Impurity D; Tomoxetine Impurity D; (3R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropylamine; LY139603 Impurity
EINECS	Contact for details

Quality Control

Every batch of Atomoxetine Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider storing under an inert atmosphere.

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 ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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