Description

Atomoxetine Related Compound B (10 Mg) (n-Methyl-3-Phenyl-3-(m-Tolyloxy)Propan-1-Amine Hydrochloride) is a high-purity reference standard and pharmaceutical impurity critical for quality control and analytical development. This compound is essential for ensuring the safety and efficacy of the active pharmaceutical ingredient Atomoxetine HCl, a non-stimulant medication used to treat ADHD. It serves as a vital tool for researchers and quality assurance professionals in pharmaceutical development, manufacturing, and regulatory compliance. The material is supplied as a precisely weighed 10 mg quantity to facilitate accurate analytical work.

Application

• Pharmaceutical Impurity Profiling and Identification in Atomoxetine HCl drug substance and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for stability-indicating assays.
• Primary Reference Standard for quantitative analysis in quality control laboratories.
• Stability Studies to monitor degradation pathways and establish shelf-life.
• Regulatory Submissions to agencies like the FDA and EMA, providing necessary impurity data.
• Research and Development of generic formulations and process chemistry optimization.
• Pharmacopoeial Testing to comply with USP, EP, or other compendial standards.

Basic Information

Product Name	Atomoxetine Related Compound B (10 Mg) (n-Methyl-3-Phenyl-3-(m-Tolyloxy)Propan-1-Amine Hydrochloride)
CAS No.	873310-28-2
Molecular Formula	C17H21NO • HCl
Molecular Weight	291.82 g/mol (Free base: 255.36 g/mol)
Synonyms	N-Methyl-3-phenyl-3-(m-tolyloxy)propan-1-amine hydrochloride; Atomoxetine Impurity B; Atomoxetine Related Substance B; (R/S)-N-Methyl-3-phenyl-3-(3-methylphenoxy)propylamine hydrochloride; LY-139603 hydrochloride; Tomoxetine Related Compound B; (3-Methylphenoxy)-3-phenyl-N-methylpropan-1-amine hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Atomoxetine Related Compound B is manufactured and analyzed under strict quality systems. The material is characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity, ensuring it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results for identity, assay, purity, and related substances. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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