Description

Atomoxetine Impurity 21 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, a 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 active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Atomoxetine HCl API and finished dosage forms.
• Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor and control impurity profiles in compliance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to confirm the identity and quantify the level of this specific impurity in production batches.
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Atomoxetine formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and control strategies.
• Research & Development: Utilized in R&D settings to study the synthesis pathways, degradation mechanisms, and pharmacokinetics of Atomoxetine-related compounds.

Basic Information

Item	Detail
Product Name	Atomoxetine Impurity 21
CAS No.	1498223-44-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atomoxetine Related Compound 21; Atomoxetine EP Impurity I; Atomoxetine USP Impurity; N-Methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine Impurity; (R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropylamine Impurity; Tomoxetine Impurity 21; (R)-Tomoxetine Impurity
EINECS	Contact for details

Quality Control

Our Atomoxetine Impurity 21 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed when not in use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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