Description

Atomoxetine Impurity D Crs is a high-purity chemical reference standard (CRS) used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of Atomoxetine HCl, a medication used to treat attention deficit hyperactivity disorder (ADHD). It is essential for professionals engaged in method development, stability studies, and regulatory compliance testing within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Quality Control (QC): Serves as a certified reference material for the identification and quantification of a specific impurity in Atomoxetine HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a traceable standard for impurity characterization in drug substance and product specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Research & Development: Utilized in chemical and pharmacological R&D to study the synthesis pathways, degradation mechanisms, and biological impact of Atomoxetine-related impurities.
• Contract Testing Laboratories: A vital reagent for third-party labs providing analytical testing services to the pharmaceutical industry, ensuring accurate and reliable results.

Basic Information

Item	Details
Product Name	Atomoxetine Impurity D Crs
CAS No.	873310-29-3
Molecular Formula	C17H21NO
Molecular Weight	255.36 g/mol
Synonyms	Atomoxetine Related Compound D; (3R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine; (R)-N-Methyl-3-phenyl-3-(o-tolyloxy)propylamine; Tomoxetine Impurity D; LY139603 Impurity D; (R)-Tomoxetine Impurity D
EINECS	Contact for details

Quality Control

Every batch of Atomoxetine Impurity D Crs is manufactured and tested under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the stringent requirements for a chemical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.